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Cell) Lung Cancer: phase 2, terminated or withdrawn","href":"/trials/nct05117242/","quote":"Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns."},{"drugId":"glofitamab","drugName":"Glofitamab","drugRoute":"/drugs/glofitamab/","drugState":"approved","record":"glofitamab","kind":"event","label":"US 2025-07-02: complete response letter","href":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","quote":"Complete response letter for STARGLO combination (regional heterogeneity); approved in EU"},{"drugId":"odronextamab","drugName":"Odronextamab","drugRoute":"/drugs/odronextamab/","drugState":"approved","record":"odronextamab","kind":"event","label":"US 2024-03-25: complete response letter","href":"/drugs/odronextamab/","quote":"CRLs for DLBCL and FL, confirmatory trial enrolment status"}],"proposed":[{"id":"bs-pdl1-ctla4","format":"bispecific","name":"PD-L1 x CTLA-4 bispecific","a":"pdl1","b":"ctla4","raw":{"a":"pdl1","b":"ctla4"},"matched":true,"unmatched":[],"rationale":"PD-L1 blockade is approved across many cancers (atezolizumab, durvalumab) and CTLA-4 blockade both alone (ipilimumab, tremelimumab) and inside a PD-1 x CTLA-4 bispecific (cadonilimab). The corpus has PD-1 x CTLA-4, PD-1 x VEGF and PD-L1 x VEGF bispecifics (cadonilimab, ivonescimab, pm8002) but no PD-L1 x CTLA-4. The PD-1 x CTLA-4 bispecific (cadonilimab) is approved and shows the format can deliver dual checkpoint blockade with less colitis than the two antibodies; PD-L1 x CTLA-4 would concentrate CTLA-4 blockade in PD-L1-rich tumour tissue rather than lymph nodes, the same avidity logic applied to the ligand side.","caveat":"It needs to show that tumour-localised CTLA-4 blockade beats the approved PD-1 x CTLA-4 bispecific or the durvalumab plus tremelimumab pair on toxicity or response, a high bar in cancers where those already work.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":81,"burden":35,"worldDeaths":3488994,"validationA":15,"validationB":15,"plausibility":16},"evidence":[{"label":"Trial: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (2022-06-15)","url":"https://clinicaltrials.gov/study/NCT05420220","quote":"KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection).","kind":"trial"},{"label":"Trial: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (2020-07-14)","url":"https://clinicaltrials.gov/study/NCT04469725","quote":"Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.","kind":"trial"},{"label":"Paper: Xu D et al. (2025-02-07)","url":"https://doi.org/10.1038/s41467-025-56537-y","quote":"The anti-PD-L1/CTLA-4 bispecific antibody KN046 plus lenvatinib in advanced unresectable or metastatic hepatocellular carcinoma: a phase II trial.","kind":"paper"}],"refs":["atezolizumab","cadonilimab","durvalumab","ipilimumab","ivonescimab","pm8002","tremelimumab"],"cancers":["nsclc","pancreatic","hcc","esophageal"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-pd1-lag3","format":"bispecific","name":"PD-1 x LAG-3 bispecific","a":"pd1","b":"lag3","raw":{"a":"pd1","b":"lag3"},"matched":true,"unmatched":[],"rationale":"PD-1 blockade is approved across cancers (pembrolizumab, nivolumab) and LAG-3 blockade is approved in a fixed-dose combination with PD-1 blockade (relatlimab-nivolumab). The corpus has PD-1 x CTLA-4, PD-1 x TIM-3 and PD-1 x TIGIT bispecifics (cadonilimab, azd7789, rilvegostomig) but no PD-1 x LAG-3 bispecific, the pair with the strongest clinical validation. The fixed-dose relatlimab plus nivolumab combination is approved (relatlimab-nivolumab), so the biology is proven; a single bispecific molecule would bind cells that co-express both receptors, exhausted tumour-infiltrating T cells, with higher avidity than two separate antibodies and could be dosed as one product.","caveat":"A PD-1 x LAG-3 bispecific reached late-stage trials and was discontinued; the new molecule would need a reason to differ, such as different epitopes, Fc design or a population defined by LAG-3 expression.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":78,"burden":34,"worldDeaths":2536311,"validationA":15,"validationB":15,"plausibility":14},"evidence":[{"label":"Trial: Akeso (2022-12-09)","url":"https://clinicaltrials.gov/study/NCT05645276","quote":"A Phase Ia/Ib, open label, dose escalation and dose extension trial of Anti-PD-1 and LAG-3 bispecific antibody, AK129, to evaluate the safety, tolerability and antitumor efficacy in patients with advanced malignant tumors","kind":"trial"},{"label":"Trial: Shanghai EpimAb Biotherapeutics Co., Ltd. (2020-11-05)","url":"https://clinicaltrials.gov/study/NCT04618393","quote":"The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds.","kind":"trial"},{"label":"Paper: Garralda E et al. (2026-07-01)","url":"https://doi.org/10.1158/1078-0432.ccr-25-4478","quote":"A First-in-Human Phase I Clinical Trial Evaluating Clinical Activity and Proof of Mechanism of Tobemstomig, a PD-1-LAG-3 Bispecific Antibody, in Patients with CPI-Experienced Melanoma.","kind":"paper"},{"label":"Paper: Long GV et al. (2025-09-24)","url":"https://doi.org/10.1038/s41591-025-03967-2","quote":"Neoadjuvant PD-1 and LAG-3-targeting bispecific antibody and other immune checkpoint inhibitor combinations in resectable melanoma: the randomized phase 1b/2 Morpheus-Melanoma trial.","kind":"paper"}],"refs":["azd7789","cadonilimab","nivolumab","pembrolizumab","relatlimab-nivolumab","rilvegostomig"],"cancers":["melanoma","advanced-melanoma","nsclc","gastric"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-folr1-cd3","format":"bispecific","name":"Folate receptor alpha x CD3 bispecific","a":"folr1","b":"cd3","raw":{"a":"folr1","b":"cd3"},"matched":true,"unmatched":[],"rationale":"Folate receptor alpha is validated by an approved ADC (mirvetuximab-soravtansine) with two more in phase 3 (rinatabart-sesutecan, luveltamab-tazevibulin), and the CD3 arm by approved solid-tumour engagers (tarlatamab). The corpus holds an ovarian engager against MUC16 (ubamatamab) but none against folate receptor alpha. Folate receptor alpha is dense and homogeneous in high-grade serous ovarian cancer and largely absent from normal tissue except the kidney tubule and choroid plexus; ovarian cancer's ascites is rich in T cells, which an engager could recruit, and the corpus already has an ovarian engager against MUC16 (ubamatamab).","caveat":"Ovarian cancer's microenvironment is immunosuppressive and checkpoint blockade has failed there; an engager may need a costimulatory partner or intraperitoneal delivery to work.","status":"preclinical evidence","statusLabel":"Preclinical","score":{"total":75,"burden":33,"worldDeaths":2122148,"validationA":15,"validationB":15,"plausibility":12},"evidence":[{"label":"Paper: Avanzino BC et al. (2022-08-20)","url":"https://doi.org/10.1080/2162402x.2022.2113697","quote":"A T-cell engaging bispecific antibody with a tumor-selective bivalent folate receptor alpha binding arm for the treatment of ovarian cancer.","kind":"paper"},{"label":"Paper: Geiger M et al. (2020-06-24)","url":"https://doi.org/10.1038/s41467-020-16838-w","quote":"Protease-activation using anti-idiotypic masks enables tumor specificity of a folate receptor 1-T cell bispecific antibody.","kind":"paper"},{"label":"Paper: Morris SM et al. (2026-04-15)","url":"https://doi.org/10.1016/j.bneo.2026.100232","quote":"Fully human anti-FOLR1 T-cell engager demonstrates potent activity in CBFA2T3::GLIS2 acute megakaryoblastic leukemia.","kind":"paper"}],"refs":["luveltamab-tazevibulin","mirvetuximab-soravtansine","rinatabart-sesutecan","tarlatamab","ubamatamab"],"cancers":["ovarian","platinum-resistant-ovarian-cancer","endometrial","nsclc"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-ceacam5-cd3","format":"bispecific","name":"CEACAM5 x CD3 bispecific","a":"ceacam5","b":"cd3","raw":{"a":"ceacam5","b":"cd3"},"matched":true,"unmatched":[],"rationale":"CEACAM5 has two ADCs in phase 3 in the corpus (precemtabart-tocentecan, tusamitamab-ravtansine) and the CD3 arm is validated in solid tumours (tarlatamab). No corpus T-cell engager targets CEACAM5, though it is the classic marker of the largest immunotherapy-resistant cancer in the corpus (colorectal). CEACAM5 is dense on colorectal and lung adenocarcinoma with limited normal expression apart from colonic epithelium; microsatellite-stable colorectal cancer has no working immunotherapy, so an engager that brings T cells in is the right shape of idea, and the shed antigen (CEA) in serum is the sink to design around.","caveat":"Soluble CEA in serum can soak up the engager and colonic epithelium expresses the antigen; a 2+1 format that needs membrane-bound density is the plausible design, and an earlier attempt found modest activity.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":73,"burden":36,"worldDeaths":3849072,"validationA":10,"validationB":15,"plausibility":12},"evidence":[{"label":"Trial: Hoffmann-La Roche (2014-12-24)","url":"https://clinicaltrials.gov/study/NCT02324257","quote":"Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical study of single-agent RO6958688 in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC.","kind":"trial"},{"label":"Paper: Segal NH et al. (2024-05-15)","url":"https://doi.org/10.1038/s41467-024-48479-8","quote":"CEA-CD3 bispecific antibody cibisatamab with or without atezolizumab in patients with CEA-positive solid tumours: results of two multi-institutional Phase 1 trials.","kind":"paper"},{"label":"Trial: Light Chain Bioscience - Novimmune SA (2024-10-29)","url":"https://clinicaltrials.gov/study/NCT06663839","quote":"Study LCB-2301-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NILK-2301 in patients with locally advanced or metastatic low tumor volume (LTV) colorectal cancer.","kind":"trial"}],"refs":["colorectal","precemtabart-tocentecan","tarlatamab","tusamitamab-ravtansine"],"cancers":["colorectal","nsclc","gastric","pancreatic"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-her2-cd3","format":"bispecific","name":"HER2 x CD3 bispecific","a":"her2","b":"cd3","raw":{"a":"her2","b":"cd3"},"matched":true,"unmatched":[],"rationale":"HER2 is validated across antibodies, ADCs and bispecifics (trastuzumab, trastuzumab-deruxtecan, zanidatamab) and the CD3 arm across seven approved engagers (blinatumomab, teclistamab, tarlatamab). The corpus has no HER2 x CD3 T-cell engager, the obvious cell for the most validated antigen and the most validated effector arm. HER2 is the most validated solid-tumour antigen, but T-cell engagers have no antigen-density threshold and HER2 is expressed at low levels on many normal epithelia; a low-affinity or avidity-dependent (2+1) format is what a HER2 x CD3 needs to spare normal tissue.","caveat":"Normal-tissue HER2 will be hit unless the CD3 arm is tuned to need high antigen density; the first-generation attempts were limited by exactly this.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":73,"burden":31,"worldDeaths":1326278,"validationA":15,"validationB":15,"plausibility":12},"evidence":[{"label":"Trial: Wuhan YZY Biopharma Co., Ltd. (2020-08-06)","url":"https://clinicaltrials.gov/study/NCT04501770","quote":"A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors","kind":"trial"},{"label":"Trial: Ichnos Sciences SA (2016-07-12)","url":"https://clinicaltrials.gov/study/NCT02829372","quote":"CD3/HER2 bispecific monoclonal antibody","kind":"trial"},{"label":"Trial: Neovii Biotech (2007-03-27)","url":"https://clinicaltrials.gov/study/NCT00452140","quote":"The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed after endocrine therapy.","kind":"trial"}],"refs":["blinatumomab","tarlatamab","teclistamab","trastuzumab","trastuzumab-deruxtecan","zanidatamab"],"cancers":["breast-her2-positive","gastric-her2-positive","her2-low-metastatic-breast-cancer"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-sstr2-cd3","format":"bispecific","name":"Somatostatin receptor 2 x CD3 bispecific","a":"sstr2","b":"cd3","raw":{"a":"sstr2","b":"cd3"},"matched":true,"unmatched":[],"rationale":"SSTR2 is validated by an approved radioligand (lutathera) and the CD3 arm in neuroendocrine cancer by an approved DLL3 engager (tarlatamab). No corpus T-cell engager targets SSTR2. SSTR2 is restricted and dense on neuroendocrine tumours, and tarlatamab proves engagers work in neuroendocrine-lineage cancer; SSTR2 on pancreatic islets, pituitary and gut endocrine cells predicts endocrine toxicity, and a GPCR is a hard antibody target.","caveat":"An SSTR2 x CD3 engager reached phase 1 and was discontinued; endocrine on-target effects and the difficulty of engaging a GPCR remain, so a new construct would need to show why it differs.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":73,"burden":33,"worldDeaths":1817469,"validationA":15,"validationB":15,"plausibility":10},"evidence":[{"label":"Trial: Xencor, Inc. (2018-01-26)","url":"https://clinicaltrials.gov/study/NCT03411915","quote":"This is a Phase 1, multiple dose, ascending dose escalation study; to define a MTD/RD and regimen consisting of a first \"priming\" dose and escalated subsequent doses of XmAb18087; to describe safety and tolerability; to assess PK and immunogenicity; and to preliminarily assess anti-tumor activity of XmAb18087 in subjects with advanced NET or GIST.","kind":"trial"},{"label":"Trial: Xencor, Inc. (2020-10-19)","url":"https://clinicaltrials.gov/study/NCT04590781","quote":"This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung ca...","kind":"trial"}],"refs":["lutathera","tarlatamab"],"cancers":["neuroendocrine","sclc","pancreatic-net"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-trop2-cd3","format":"bispecific","name":"TROP2 x CD3 bispecific","a":"trop2","b":"cd3","raw":{"a":"trop2","b":"cd3"},"matched":true,"unmatched":[],"rationale":"TROP2 carries three approved ADCs (sacituzumab-govitecan, datopotamab-deruxtecan, sacituzumab-tirumotecan) and the CD3 arm is validated in solid tumours by tarlatamab (tarlatamab). No corpus T-cell engager targets TROP2. TROP2 is on normal skin, oesophagus and other epithelia; an ADC tolerates this because payload delivery scales with antigen density, but a CD3 engager kills at low density, so the window is narrow unless the CD3 arm is masked or avidity-gated.","caveat":"Normal-epithelium expression predicts on-target toxicity; a protease-masked or 2+1 avidity format would be needed to have any window.","status":"no public evidence","statusLabel":"No public evidence","score":{"total":73,"burden":35,"worldDeaths":3171577,"validationA":15,"validationB":15,"plausibility":8},"evidence":[],"refs":["datopotamab-deruxtecan","sacituzumab-govitecan","sacituzumab-tirumotecan","tarlatamab"],"cancers":["tnbc","nsclc","urothelial","pancreatic"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-psma-cd3","format":"bispecific","name":"PSMA x CD3 bispecific","a":"psma","b":"cd3","raw":{"a":"psma","b":"cd3"},"matched":true,"unmatched":[],"rationale":"PSMA is validated by an approved radioligand (pluvicto) and the CD3 arm by seven approved engagers (blinatumomab, teclistamab). The corpus has prostate T-cell engagers against STEAP1 and KLK2 (xaluritamig, pasritamig) and a PSMA x CD28 costimulator (jnj-87189401) but no PSMA x CD3 engager, so the cell is untried in the corpus. PSMA is tumour-restricted enough for a radioligand and the corpus already holds prostate engagers against STEAP1 (xaluritamig) and KLK2 (pasritamig) and a PSMA x CD28 costimulatory bispecific (jnj-87189401); the prostate microenvironment's T-cell exclusion and cytokine release at active doses are the obstacles.","caveat":"Several PSMA x CD3 engagers reached the clinic and were stopped for cytokine release or limited activity; a new attempt needs a reason to differ, such as half-life extension, subcutaneous step-up dosing or pairing with the PSMA x CD28 costimulator.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":70,"burden":26,"worldDeaths":397430,"validationA":15,"validationB":15,"plausibility":14},"evidence":[{"label":"Trial: Amgen (2021-02-05)","url":"https://clinicaltrials.gov/study/NCT04740034","quote":"This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy.","kind":"trial"},{"label":"Paper: Dorff T et al. (2024-04-01)","url":"https://doi.org/10.1158/1078-0432.ccr-23-2978","quote":"A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer.","kind":"paper"}],"refs":["blinatumomab","jnj-87189401","pasritamig","pluvicto","teclistamab","xaluritamig"],"cancers":["prostate-mcrpc"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-nectin4-cd3","format":"bispecific","name":"Nectin-4 x CD3 bispecific","a":"nectin4","b":"cd3","raw":{"a":"nectin4","b":"cd3"},"matched":true,"unmatched":[],"rationale":"Nectin-4 is validated by an approved ADC (enfortumab-vedotin) and the CD3 arm by tarlatamab in solid tumours (tarlatamab). No corpus T-cell engager targets Nectin-4. Nectin-4 is dense in urothelial cancer with skin as the main normal site; bladder cancer responds to immunotherapy, so T cells are present, and enfortumab plus pembrolizumab already shows the antigen and immune activation can be combined.","caveat":"Skin expression of Nectin-4 would produce on-target dermatitis from an engager as it does from the ADC; whether that is tolerable at active doses is unknown.","status":"no public evidence","statusLabel":"No public evidence","score":{"total":69,"burden":29,"worldDeaths":886699,"validationA":15,"validationB":15,"plausibility":10},"evidence":[],"refs":["enfortumab-vedotin","tarlatamab"],"cancers":["urothelial","tnbc"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-cd123-cd3","format":"bispecific","name":"CD123 x CD3 bispecific","a":"cd123","b":"cd3","raw":{"a":"cd123","b":"cd3"},"matched":true,"unmatched":[],"rationale":"CD123 is validated by an approved ADC (pivekimab-sunirine) and an approved toxin fusion (tagraxofusp), and the CD3 arm by blinatumomab (blinatumomab). No corpus T-cell engager targets CD123. CD123 covers leukaemic stem cells and is uniformly high in BPDCN, a disease where tagraxofusp already validates the antigen; capillary leak and cytokine release are the toxicities, and BPDCN's rarity limits trials.","caveat":"Earlier CD123 x CD3 engagers showed activity mainly in a TP53-mutant subgroup and were limited by cytokine release; a new one would need to define its population first.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":67,"burden":25,"worldDeaths":305405,"validationA":15,"validationB":15,"plausibility":12},"evidence":[{"label":"Trial: MacroGenics (2014-06-02)","url":"https://clinicaltrials.gov/study/NCT02152956","quote":"Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)","kind":"trial"},{"label":"Trial: Children's Oncology Group (2019-11-12)","url":"https://clinicaltrials.gov/study/NCT04158739","quote":"This phase I trial studies the side effects, best dose of flotetuzumab and how well it works in treating patients with acute myeloid leukemia (AML) that has come back (recurrent) or has not responded to treatment (refractory).","kind":"trial"},{"label":"Trial: MacroGenics (2022-05-05)","url":"https://clinicaltrials.gov/study/NCT05362773","quote":"CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment.","kind":"trial"}],"refs":["blinatumomab","pivekimab-sunirine","tagraxofusp"],"cancers":["aml","bpdcn","mds"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-cd33-cd3","format":"bispecific","name":"CD33 x CD3 bispecific","a":"cd33","b":"cd3","raw":{"a":"cd33","b":"cd3"},"matched":true,"unmatched":[],"rationale":"CD33 is validated by an approved ADC (gemtuzumab-ozogamicin) and the CD3 arm by blinatumomab in the neighbouring lymphoid leukaemia (blinatumomab). No corpus T-cell engager targets a myeloid antigen, so the CD33 x CD3 cell is untried in the corpus. AML is the natural haematological extension of blinatumomab's success in ALL; the problems are low T-cell numbers in AML patients, myeloid-cell CD33 causing cytokine release, and the leukaemia's immunosuppressive niche.","caveat":"Several CD33 x CD3 engagers reached phase 1 with modest response rates and cytokine release; the case for a new one rests on half-life extension and use in measurable residual disease rather than bulk relapse.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":67,"burden":25,"worldDeaths":305405,"validationA":15,"validationB":15,"plausibility":12},"evidence":[{"label":"Trial: Janssen Research & Development, LLC (2019-04-16)","url":"https://clinicaltrials.gov/study/NCT03915379","quote":"The main purpose of this study are to determine the recommended Phase 2 dose(s) (RP2D) route of administration, schedule and the maximum tolerated dose (MTD) in Part 1 and to determine the safety and tolerability of JNJ-67571244 at the RP2D regimen(s) and to evaluate the preliminary clinical activity of JNJ-67571244 in Part 2.","kind":"trial"},{"label":"Trial: Amphivena Therapeutics, Inc. (2018-05-04)","url":"https://clinicaltrials.gov/study/NCT03516591","quote":"An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes","kind":"trial"},{"label":"Trial: Y-mAbs Therapeutics (2021-10-14)","url":"https://clinicaltrials.gov/study/NCT05077423","quote":"A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia","kind":"trial"}],"refs":["blinatumomab","gemtuzumab-ozogamicin"],"cancers":["aml","aml-older-unfit"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"},{"id":"bs-cd38-cd3","format":"bispecific","name":"CD38 x CD3 bispecific","a":"cd38","b":"cd3","raw":{"a":"cd38","b":"cd3"},"matched":true,"unmatched":[],"rationale":"CD38 is validated by two approved antibodies (daratumumab, isatuximab) and the CD3 arm by three approved myeloma engagers (teclistamab, elranatamab, talquetamab). The corpus has a trispecific that includes CD38 (isb-2001) but no CD38 x CD3 bispecific. Myeloma engagers against BCMA and GPRC5D work, and CD38 is dense on plasma cells; but CD38 is on activated T cells and NK cells, so an engager would attack its own effectors, and the corpus already holds a BCMA x CD38 x CD3 trispecific (isb-2001) that uses CD38 as an avidity arm.","caveat":"An earlier CD38 x CD3 was stopped after phase 1, and CD38 on T cells makes fratricide a structural problem; the trispecific route, where CD38 adds avidity rather than being the sole target, may be the only viable form.","status":"clinical evidence","statusLabel":"Clinical evidence","score":{"total":61,"burden":21,"worldDeaths":121388,"validationA":15,"validationB":15,"plausibility":10},"evidence":[{"label":"Trial: Wuhan YZY Biopharma Co., Ltd. (2021-08-18)","url":"https://clinicaltrials.gov/study/NCT05011097","quote":"The main purpose of this Phase I study is to access the safety and tolerability of Y150 at different dose levels.","kind":"trial"},{"label":"Paper: Pouleau B et al. (2023-07-01)","url":"https://doi.org/10.1182/blood.2022019451","quote":"Preclinical characterization of ISB 1342, a CD38 × CD3 T-cell engager for relapsed/refractory multiple myeloma.","kind":"paper"},{"label":"Paper: Zabaleta A et al. (2024-09-22), neighbouring cell","url":"https://doi.org/10.1111/bjh.19784","quote":"A CD38/CD3xCD28 trispecific T-cell engager as a potentially active agent in multiple myeloma patients relapsed and/or refractory to anti-CD38 monoclonal antibodies.","kind":"paper","adjacent":true}],"refs":["daratumumab","elranatamab","isatuximab","isb-2001","talquetamab","teclistamab"],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"proposedBy":"OnCo open pipeline","on":"2026-09-23"}],"note":"Every state is derived from the records named in evidence; untried means no medicine in this corpus combines the two parts. Proposed cells are hypotheses from the open pipeline (docs/OPEN-PIPELINE.md), not records of a medicine. CC BY-NC 4.0, attribute Data from OnCo (onco.cc). Not medical advice."}