Drugs / Anitocabtagene Autoleucel
Anitocabtagene Autoleucel
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04155749 | Dec 2019 → Oct 2024 overdue | refractory plasma cell neoplasm | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07045909 | Jun 2025 → Mar 2028 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT05396885 | Jul 2022 → Dec 2026 expected | plasma cell myeloma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06413498 | Aug 2024 → Jul 2028 expected | plasma cell myeloma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | Gilead Sciences | Regulatory Gilead Sciences Announces First Quarter Financial Results gilead.com ↗
Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026. |
| 2025-12-06 | Kite, A Gilead Company | Results Kite Announces New Data for Pivotal iMMagine-1 Study at ASH 2025, Highlighting Anito-cel’s Opportunity in Relapsed or Refractory Multiple Myeloma kitepharma.com ↗
96% Overall Response Rate, 74% Stringent Complete Response/Complete Response, and 95% Minimal Residual Disease Negativity Observed at a Median 15.9-months of Follow-up, with Responses Continuing to Deepen Over Time |
| 2025-12-06 | Gilead Sciences | Results Kite Announces New Data for Pivotal iMMagine-1 Study at ASH 2025, Highlighting Anito-cel’s Opportunity in Relapsed or Refractory Multiple Myeloma gilead.com ↗
I am encouraged by the depth of responses in the iMMagine-1 study. |
| 2025-11-03 | Kite, A Gilead Company | Results Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 kitepharma.com ↗
Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment. |
| 2025-11-03 | Gilead Sciences | Results Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 gilead.com ↗
Key presentations for anitocabtagene autoleucel (anito-cel) include updated results from the fully enrolled, ongoing iMMagine-1 Phase 2 pivotal study. |
| 2024-11-05 | Kite, A Gilead Company | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World kitepharma.com ↗
Key presentations for anitocabtagene autoleucel (anito-cel) include data from the Phase 1 study that demonstrate a 30.2-month median progression-free survival (PFS) with a median follow-up of 38.1 months and the median overall survival not yet reached; |
| 2024-11-05 | Gilead Sciences | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World gilead.com ↗
Both the Phase 1 and Phase 2 iMMagine-1 studies highlight durable responses in patients with relapsed or refractory (R/R) multiple myeloma (MM) and show no delayed neurotoxicities have been observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain Barre syndrome. |
| 2024-05-09 | Gilead Sciences | Regulatory Kite and Arcellx Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program gilead.com ↗
This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration. |
All press releases naming this drug 10 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anitocabtagene Autoleucel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06413498 ↗ |
| Known as | Anitocabtagen autoleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314723 ↗ |
| Known as | CART-ddBCMA | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314723 ↗ |
| Modality | Cell therapy | “Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.” NCT05396885 ↗ |
| Route | Intravenous | “Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously” NCT05396885 ↗ |