Anitocabtagene Autoleucel is a BCMA directed CAR T cell therapy in development for multiple myeloma.
SparkCures ID | 363 |
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Developed By | Arcellx, Inc. |
Generic Name | Anitocabtagene Autoleucel |
Additional Names | CART-ddBCMA, ACLX-001, Anito-Cel |
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View all active clinical trials around the US.
The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.
The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.
December 09, 2024
As of June 1, 2024, 58 pts had received anito-cel infusion under the final manufacturing process with ≥2 months of follow-up after infusion; median follow-up was 10.3 months (range, 2.0-17.8). Median age was 66 years (range, 38-77). Pts had received a median of 4 prior LoT (range, 3-8) with 26 pts (45%) having received only 3 prior LoT. Forty pts (69%) were triple-class refractory and 20 (34%) were penta-class refractory. Investigator-assessed ORR per IMWG criteria was 95% (55/58) with a CR/sCR rate of 62% (36/58). Of those evaluable for MRD testing (n=39), 36 (92%) achieved MRD negativity at least to the level of 10-5. The Kaplan–Meier-estimated 6-month PFS and overall survival (OS) rates (95% CI) were 90% (77-96) and 95% (85-98), respectively; median PFS and OS have not yet been reached.
Any grade (Gr) CRS was observed in 49 pts (84%). Notably, 46 pts (79%) had either no CRS (n=9, 16%) or Gr 1 CRS (n=37, 64%). Additionally, Gr 2 CRS events occurred in 11 pts (19%), and 1 pt (2%) had a Gr 5 CRS event. The median time to CRS onset was 2 days (range, 1-17) with a median duration of 3 days (range, 1-9). Of note, 31 pts (53%) had no fever or CRS in the first 3 days of anito-cel.
Any Gr ICANS was observed in 5 pts (9%): 2 (3%) Gr 1, 2 (3%) Gr 2, and 1 (2%) Gr 3 events. Median time to ICANS onset was 5 days (range, 2-7) with a median duration of 6 days (range, 1-10); all cases resolved without sequelae. No delayed neurotoxicity, cranial nerve palsies, Guillain Barre syndrome, or Parkinsonian-like symptoms were observed. Cytopenias were the most common Gr ≥3 treatment-emergent adverse events (AEs); 36 pts (62%) had Gr ≥3 neutropenia, 15 (26%) had Gr ≥3 thrombocytopenia, and 15 (26%) had Gr ≥3 anemia. Three deaths occurred due to AEs (both related and unrelated; retroperitoneal hemorrhage, CRS, fungal infection).
Conclusions: Preliminary results from the first 58 pts in the Phase 2 iMMagine-1 trial demonstrate deep and durable efficacy and manageable safety in a high-risk 4L+ RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicity, cranial nerve palsies, Guillain Barre syndrome, or Parkinsonian-like symptoms were observed in the Phase 1 study or in the Phase 2 iMMagine-1 study to date. Updated data with additional follow-up will be presented.