{"entity":{"id":"paper-ciltacabtagene-autoleucel-multiple-myeloma-clin-cancer-res-2024","kind":"paper","name":"FDA Approval Summary: Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma","aka":[],"tldr":"Phase 2 or 3 results paper on Ciltacabtagene autoleucel in Multiple myeloma, in Clinical Cancer Research (2024), one of the most cited Europe PMC records with Ciltacabtagene autoleucel in its title.","summary":"In February 2022, the FDA approved ciltacabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy targeting the B-cell maturation antigen, for adult patients with relapsed/refractory multiple myeloma after ≥4 lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Approval was based on overall response rate (ORR), complete response (CR) rate, and duration of response (DoR) in 97 adult patients in a single-arm, open-label, multicenter phase 2 trial (CARTITUDE-1 [NCT03548207]). Patients received a single infusion of ciltacabtagene autoleucel, preceded by lymphodepleting chemotherapy. Of the 97 patients evaluable, ORR was 97.9% [95% confidence interval (CI), 92.7-99.7] with a stringent CR rate of 78.4% (95% CI, 68.8-86.1). After median follow-up of 18 months, the median DoR was 21.8 months (95% CI, 21.8-not estimable [NE]) in responders (PR or better) and NE (95% CI, 21.8 months-NE) in patients who achieved stringent CR. Serious adverse reactions occurred in 55% of the 97 patients evaluated for safety. Grade 3 or higher cytokine release syndrome (CRS) and neurologic toxicities occurred in 5% and 11% of the patients, respectively, leading to a Risk Evaluation and Mitigation Strategy. Neurologic toxicities included immune effector cell-associated neurologic syndrome, typically seen with CAR-T products, parkinsonism, peripheral neuropathy, cranial nerve palsies, and Guillain-Barré syndrome. One fatal case of hemophagocytic lymphohistiocytosis/macrophage activation syndrome occurred. Prolonged and recurrent grade 3 or 4 cytopenias occurred; a single patient required hematopoietic stem-cell rescue.\n\nIndexed on Europe PMC as PubMed record 38713595 (DOI 10.1158/1078-0432.ccr-24-0378). Its title names Ciltacabtagene autoleucel and its text names Multiple myeloma; PubMed types it as a clinical trial report (Clinical Trial, Phase II, research-article, Multicenter Study). It was matched automatically to the idea \"One CAR-T infusion instead of autologous transplant\" and no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Clin Cancer Res 2024","url":"https://doi.org/10.1158/1078-0432.ccr-24-0378"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/38713595/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/38713595"},{"label":"ClinicalTrials.gov NCT03548207","url":"https://clinicaltrials.gov/study/NCT03548207"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["cartitude-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["clinical-cancer-research"],"dependsOn":[],"notes":[],"journal":"Clinical Cancer Research","year":2024,"doi":"10.1158/1078-0432.ccr-24-0378","pmid":"38713595","authors":"Natrajan K, Kaushal M, George B, et al.","paperType":"observational","findings":[],"whatItMeans":"One of the most cited trial reports Europe PMC returns for Ciltacabtagene autoleucel in Multiple myeloma, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.","caveats":["Matched by Ciltacabtagene autoleucel in the title and Multiple myeloma in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper."]},"route":"/key-papers/paper-ciltacabtagene-autoleucel-multiple-myeloma-clin-cancer-res-2024/","neighbours":{"trial":[{"id":"cartitude-1","kind":"trial","name":"CARTITUDE-1","route":"/trials/cartitude-1/"}],"journal":[{"id":"clinical-cancer-research","kind":"journal","name":"Clinical Cancer Research","route":"/journals/clinical-cancer-research/"}],"idea":[{"id":"idea-car-t-replaces-transplant","kind":"idea","name":"One CAR-T infusion instead of autologous transplant","route":"/ideas/idea-car-t-replaces-transplant/"}]}}