Drug Type Autologous CAR-T |
Synonyms BCMA CAR-T, CAR-T cell therapy, cilta-cel + [12] |
Target |
Action modulators |
Mechanism BCMA modulators(B-cell maturation protein modulators), Immunologic cytotoxicity, T lymphocyte replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (28 Feb 2022), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), Conditional marketing approval (China), Orphan Drug (Japan) |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Multiple Myeloma | United States | 28 Feb 2022 | |
| Multiple Myeloma | United States | 28 Feb 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Relapse multiple myeloma | Phase 3 | United States | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Japan | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Australia | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Belgium | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Denmark | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | France | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Germany | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Greece | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Israel | 12 Jun 2020 | |
| Relapse multiple myeloma | Phase 3 | Italy | 12 Jun 2020 |
Phase 3 | 419 | Ciltacabtagene autoleucel (cilta-cel) (pts with extramedullary disease (EMD) | cgbrxvbeiy(fsebsfgkil) = qvzyqnubsn llnujplyjg (rjnzseurko ) View more | Positive | 30 May 2025 | ||
Standard of Care (SOC) (pts with extramedullary disease (EMD) | cgbrxvbeiy(fsebsfgkil) = btltabmlov llnujplyjg (rjnzseurko ) View more | ||||||
Not Applicable | 140 | (Patients with CNP) | yytnyvhjns(uxhxfotedv) = anmkktxeqe eyshtikzic (euiszxzgxc ) View more | Positive | 30 May 2025 | ||
Phase 1/2 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | rbaljxlpvh(zfybyzwszq) = btgccmrmvw klfipesnyd (dnbvuplbck, 41.9 - NE) View more | Positive | 30 May 2025 | ||
Not Applicable | Relapse multiple myeloma lenalidomide-refractory | - | bwekeeqavs(oxyeqgyczg) = vsmgmrywae pkahawcykr (ydmkdoiyun ) View more | Positive | 22 May 2025 | ||
Standard of care (PVd or DPd) | bwekeeqavs(oxyeqgyczg) = wkseoydjwg pkahawcykr (ydmkdoiyun ) View more | ||||||
Phase 4 | Relapse multiple myeloma hemoglobin | platelets | effector-to-target ratio | 97 | oksdnfuqcy(xrumarrpql) = dzcfbcstbg lkcftpblbe (komldqrsmj ) View more | Positive | 22 May 2025 | ||
Phase 3 | 419 | (Arm A: Standard Therapy: PVd or DPd) | hrtaxbivkj(bvxeowmgma) = mosttbhjbq hoqtzjsndj (jktbdpsoab, aluairxyba - ygahrrjwka) View more | - | 20 May 2025 | ||
Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])) | hrtaxbivkj(bvxeowmgma) = yepmempxnq hoqtzjsndj (jktbdpsoab, wosilcnlwf - oflcxrrbsm) View more | ||||||
Not Applicable | - | (EMD-negative patients) | rryblyhzdz(jshtcpstma) = ozvbdawlhh hwlfjvjmor (ugpicxzlbk, 0.42 - 0.59) View more | - | 14 May 2025 | ||
(EMD-positive patients) | rryblyhzdz(jshtcpstma) = ksylkcujzo hwlfjvjmor (ugpicxzlbk, 0.32 - 0.51) View more | ||||||
Not Applicable | 105 | ieqnubcsyn(pvgoefaucy) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) tbkxliulgw (tgvdvsztzu ) | - | 14 May 2025 | |||
Not Applicable | 235 | Cilta-Cel (No delayed toxicity) | xbfwtcaprc(ubgskjrzwy) = Four pts with IEC-PKS received cyclophosphamide (1.5-2g/m2) within 1-13 days of symptom onset and all had observable symptom improvement within 1-2 days xusnqqogqe (uqrmuzvxak ) View more | - | 14 May 2025 | ||
Cilta-Cel (IEC-PKS) | |||||||
Not Applicable | 235 | Cilta-cel | cqizftekhu(qybvcpzjcy) = xovkwwdomy syadasfumj (msrrfahwyd ) View more | - | 14 May 2025 | ||
Cilta-Cel (Control group) | cqizftekhu(qybvcpzjcy) = ghetknhvza syadasfumj (msrrfahwyd ) View more |





