{"entity":{"id":"nxc-201-mm","kind":"trial","name":"HBI0101 (NXC-201) multiple myeloma phase 1","aka":["HBI0101 phase 1","NXC-201 phase 1","MOH_2020-12-22_009584"],"tldr":"Hadassah's home-made BCMA CAR-T, now called NXC-201, produced responses in three quarters of heavily pretreated myeloma patients in its first 20-patient study, with only mild cytokine release and no nerve toxicity, showing that a hospital can manufacture its own CAR-T cells.","summary":"NCT04720313 is a phase 1 dose-escalation and safety study at Hadassah Medical Organization of HBI0101, a second-generation anti-BCMA CAR-T cell therapy developed and manufactured in an academic setting and infused fresh without cryopreservation, in relapsed or refractory BCMA-expressing multiple myeloma. Nexcella (now Immix Biopharma) is the collaborator and has taken the product forward as NXC-201.\n\nThe Haematologica 2023 report covers the first 20 heavily pretreated patients in three cohorts: 150 million CAR-T cells (6 patients), 450 million (7) and 800 million (7). Grade 1 or 2 cytokine release syndrome occurred in 18 patients (90 percent); there was no grade 3 or 4 cytokine release syndrome, no neurotoxicity of any grade and no dose-limiting toxicity in any cohort. The overall response rate was 75 percent, with a (stringent) complete response in 50 percent and a very good partial response in 25 percent. Responses were dose dependent: in the 800 million cohort the overall response rate was 85 percent, complete response 71 percent and minimal residual disease negativity 57 percent. Across cohorts the median overall survival was 308 days (range 25 to more than 466) and median progression-free survival 160 days at the June data cutoff, with six patients still progression free.\n\nThe registry lists the study as active, not recruiting, with an estimated 160 participants and a condition field reading \"Dose Escalation and Safety\" rather than a cancer, which is why the automated pass never attached it. The product's larger registered programme, NEXICART-2 (NCT06097832), is in AL amyloidosis and is a separate study.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04720313","url":"https://clinicaltrials.gov/study/NCT04720313"},{"label":"Haematologica 2023","url":"https://doi.org/10.3324/haematol.2022.281628"}],"tags":[],"related":[],"cancers":["multiple-myeloma"],"sections":[],"technologies":["car-t"],"targets":["bcma"],"drugs":["nxc-201-car-t"],"companies":["immix-biopharma"],"institutions":["hadassah"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nxc-201-hbi0101-asherie-haematologica-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04720313","phase":"1","setting":"Relapsed or refractory BCMA-expressing multiple myeloma: academic autologous anti-BCMA CAR-T HBI0101 (now NXC-201), given fresh without cryopreservation, in a dose escalation of 150, 450 and 800 million CAR-T cells","sponsor":"Hadassah Medical Organization","result":"Overall response rate 75%, (stringent) complete response 50% and very good partial response 25% in the first 20 patients; grade 1 to 2 cytokine release syndrome in 90%, no grade 3 to 4 cytokine release syndrome or neurotoxicity; median progression-free survival 160 days.","yearReported":2023,"enrolled":20,"enrolledBasis":"treated","enrolledNote":"The Haematologica 2023 report covers the first 20 heavily pretreated patients treated across three dose cohorts (6, 7 and 7); ClinicalTrials.gov NCT04720313 lists an estimated enrolment of 160 for the continuing study.","outcomes":[{"endpoint":"Overall response rate","primary":true,"unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":75,"note":"(Stringent) complete response 50%, very good partial response 25%; 85% in the 800 million cell cohort (7 patients)"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"(Stringent) complete response rate","unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":50,"note":"71% in the 800 million cell cohort, with 57% minimal residual disease negativity"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"Median progression-free survival","unit":"days","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":160,"note":"Median overall survival 308 days (range 25 to more than 466); six patients progression free at the data cutoff"}],"source":"https://doi.org/10.3324/haematol.2022.281628"},{"endpoint":"Grade 1 to 2 cytokine release syndrome","unit":"%","arms":[{"name":"HBI0101 (NXC-201), all dose cohorts","n":20,"value":90,"note":"18 of 20; no grade 3 to 4 cytokine release syndrome, no neurotoxicity of any grade, no dose-limiting toxicity"}],"source":"https://doi.org/10.3324/haematol.2022.281628"}],"replication":"Single-centre academic phase 1; the approved BCMA CAR-T products idecabtagene vicleucel and ciltacabtagene autoleucel reached registration through larger multicentre trials. NEXICART-2 (NCT06097832) tests the same cells in AL amyloidosis and has not reported."},"route":"/trials/nxc-201-mm/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"drug":[{"id":"nxc-201-car-t","kind":"drug","name":"NXC-201 CAR-T","route":"/drugs/nxc-201-car-t/"}],"company":[{"id":"immix-biopharma","kind":"company","name":"Immix Biopharma","route":"/companies/immix-biopharma/"}],"institution":[{"id":"hadassah","kind":"institution","name":"Hadassah Medical Center","route":"/institutions/hadassah/"}],"paper":[{"id":"paper-nxc-201-hbi0101-asherie-haematologica-2023","kind":"paper","name":"Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial (HBI0101)","route":"/key-papers/paper-nxc-201-hbi0101-asherie-haematologica-2023/"}]}}