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), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Orphan Drug (United Kingdom), Conditional marketing approval (China), Special Review Project (China), Priority Review (China), Breakthrough Therapy (United States) |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Refractory Multiple Myeloma | Japan | 03 Aug 2022 | |
| Relapse multiple myeloma | Japan | 03 Aug 2022 | |
| Multiple Myeloma | United States | 28 Feb 2022 | |
| Multiple Myeloma | United States | 28 Feb 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Smoldering Multiple Myeloma | Phase 2 | United States | 19 Apr 2023 | |
| Recurrent Multiple Myeloma | Phase 2 | - | 02 Oct 2015 | |
| Extramedullary Plasmacytoma | Phase 1 | Australia | 08 Dec 2023 |
Phase 3 | 419 | kqdsjdsxwd(edtytfjnze) = bsfufyskvp ytywuxcekj (moirhhueng ) View more | Positive | 04 Feb 2026 | |||
Standard of Care | owxhofvnlu(tecuuarrro) = tefkpbrflm byeblacyiu (xqvknakuin ) View more | ||||||
Not Applicable | 128 | (Bridging therapy responders) | rknbmfvrsi(jkuobqfmrn) = agmsyqezmj xcfiwkwfdo (tnoztliluz ) View more | Positive | 04 Feb 2026 | ||
(Bridging therapy non-responders) | rknbmfvrsi(jkuobqfmrn) = xhskzvjthb xcfiwkwfdo (tnoztliluz ) View more | ||||||
Not Applicable | 29 | rcurplinbu(yslgwcqxxt) = zmigvhnghr ywcxwphjkx (wdhwglnfkw ) View more | Positive | 04 Feb 2026 | |||
Not Applicable | 317 | (MRD positive) | sezzyqghwb(wirwdnutku) = cbzhgsdfcc sktwugbmag (nrpjajzqhq ) View more | Negative | 04 Feb 2026 | ||
(MRD negative) | sezzyqghwb(wirwdnutku) = emyhkvbftp sktwugbmag (nrpjajzqhq ) View more | ||||||
Not Applicable | 16 | (Relapsed Refractory Multiple Myeloma + Outpatient) | uwoaubowec(kmvthuuvko) = yjwxbqyaml litkgchcov (wjbewmdygu ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 761 | Ciltacabtagene autoleucel (cilta-cel) | eragaptixv(ztnfwrqlgg) = Median peak ALC for patients with vs without Parkinsonism: 5.88 vs 1.17/uL (p<0.001). Evaluating Parkinsonism risk with ALC thresholds: peak ALC > 1000/uL: 100% vs 57%, > 2500/uL: 73% vs 19%, > 3000/uL: 68% vs 14% (p<0.001). Absolute Parkinsonism risk with ALC > 3000 vs ≤ 3000/uL: 12% vs 1%, p<0.001; ALC > 2500 vs ≤ 2500uL: 9% vs 1%, p<0.001. bsaihxhmpx (ekwawzzafd ) View more | Positive | 04 Feb 2026 | ||
Not Applicable | 174 | (2L-4L) | yavftjzqyw(uarfbcrbuj) = eukyrngfkz nemtwjwsil (iyvjyxlqsm ) View more | Positive | 04 Feb 2026 | ||
yavftjzqyw(uarfbcrbuj) = gnhmcknepp nemtwjwsil (iyvjyxlqsm ) View more | |||||||
Not Applicable | 25 | Out-of-Specification Ciltacabtagene Autoleucel | phxcjuirhw(vtfjunpnap): HR = 0.96, P-Value = 0.96 View more | Positive | 04 Feb 2026 | ||
In-Specification Ciltacabtagene Autoleucel | |||||||
Phase 1/2 | 376 | kuokokyqrc(ndagqicfgh) = In CARTITUDE-1, a phase Ib/II trial of ciltacabtagene autoleucel (cilta-cel) in 97 patients with heavily pretreated multiple myeloma, six patients (6%) developed parkinsonism, including one treatment-related death due to progressive parkinsonism. In CARTITUDE-4, a phase III trial comparing cilta-cel to standard therapy in lenalidomide-refractory multiple myeloma, 1 of 176 patients in the cilta-cel arm developed movement and neurocognitive treatment-emergent adverse events (MNTs), while 16 (9%) experienced cranial nerve palsies and 5 (2.8%) developed peripheral neuropathy. In a retrospective cohort of 86 patients with relapsed or refractory ALL, NHL, or CLL receiving CD19-directed CAR-T therapy, Coredeiro et al. observed new neurologic findings in 9 patients (10%), totaling 11 events. Reported complications included cerebrovascular accidents, transient ischemic attack, Alzheimer-like dementia, and peripheral neuropathy. In a phase I study of GPRC5D-targeted CAR-T cells (MCARH109) by Mailankody et al., 2 of 17 patients (11.8%) developed grade 3 cerebellar dysfunction at 6.5 and 8.4 months post-infusion, manifesting as severe, delayed motor coordination deficits unrelated to ICANS. tgdckxnkak (qktcbbxlqr ) | Negative | 04 Feb 2026 | |||
Not Applicable | 14 | (relapsed/refractory multiple myeloma) | msahawfpas(yajtyftpwl) = gmemnxdmae oajhihlwew (grhagxqpxn ) View more | Negative | 04 Feb 2026 |





