Chimeric antigen receptor T-cell (CAR-T) therapy targeting BCMA has transformed the treatment of relapsed/refractory multiple myeloma (RRMM). Anitocabtagene autoleucel (anito-cel) is an autologous anti- BCMA CAR-T therapy with a novel D-domain binder used to treat patients with RRMM. Here, we report the safety, tolerability, and clinical activity of anito-cel across phase 1 and phase 2 portions of the iMMagine-1 trial. 

Eligible patients had RRMM with ≥3 prior lines of therapy (including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibody). Patients received a single infusion of anito-cel following standard lymphodepletion (fludarabine and cyclophosphamide). Compared results from both iMMagine-1 trials thus far. 

Anito-cel continues to demonstrate a manageable safety profile and deep, durable responses in patients with RRMM. The consistency of high MRD-negativity rates and prolonged PFS across both phases supports its potential as a highly efficacious BCMA-targeted therapy. BCMA: B-cell maturation antigen, CD: cluster of differentiation, CR: complete response, ICANS: immune effector cell–associated neurotoxicity syndrome, MRD: measurable residual disease, OS: overall survival, PFS: progression-free survival, sCR: stringent complete response 

Table 1. Composite Data for IMMagine-1 Phase 1 and 2 

Evaluated 96 heavily pretreated patients with RRMM (Phase 1: n=38; Phase 2: n=58) with a median of 4 prior lines of therapy. 

High baseline disease burden with triple-class refractory disease present in 100% (Phase 1) and 69% (Phase 2) of patients, alongside penta-class refractoriness in 68% and 34%, respectively. 

Demonstrated robust clinical activity, reaching an ORR of 100% in Phase 1 and 95% in Phase 2, with deep complete responses (CR/sCR: 79% vs. 62%). 

Deep responses corresponded with high MRD negativity rates of 89% (Phase 1) and 92% (Phase 2) among evaluable patients. 

Durability was preserved across cohorts: 27-month PFS and OS rates reached 52% and 78% in Phase 1 (median follow-up: 34 months), while Phase 2 showed 6-month PFS and OS rates of 90% and 95% (median follow-up: 10.3 months). 

Manageable safety profile across phases, with CRS occurring in 95% of Phase 1 and 84% of Phase 2 patients. 

Neurotoxicity was infrequent and mostly low-grade; any-grade ICANS occurred in 18% (Phase 1) and 9% (Phase 2), with Grade >=3 ICANS remaining low at 5% and 2%, respectively. 

Frigault MJ, Bishop MR, Rosenblatt J, et al. Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. Blood Adv. 2023;7(5):768-777. doi:10.1182/bloodadvances.2022007210 

Frigault MJ, Rosenblatt J, Dhakal B, et al. Phase 1 study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM): efficacy and safety with 34-month median follow-up. Abstract presented at: 66th American Society of Hematology (ASH) Annual Meeting & Exposition; December 7-10, 2024; San Diego, CA. Abstract 4828. 

First-in-human study of CART-ddBCMA in subjects with relapsed or refractory multiple myeloma. ClinicalTrials.gov identifier: NCT04155749. Updated May 17, 2024. Accessed August 22, 2026. https://clinicaltrials.gov/study/NCT04155749 

Patel KK, Dhakal B, Kaur G, et al. A phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory myeloma: updated results from iMMagine-1. Abstract presented at: 67th American Society of Hematology (ASH) Annual Meeting & Exposition; December 6-9, 2025; Orlando, FL. Abstract 256. 

Freeman CL, Dhakal B, Kaur G, et al. Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: preliminary results from the iMMagine-1 trial. Blood. 2024;144(suppl 1):1031. doi:10.1182/blood-2024- 201655 

A phase 2 open-label study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (iMMagine-1). ClinicalTrials.gov identifier: NCT05396885. Updated February 11, 2026. Accessed August 22, 2026. https://clinicaltrials.gov/study/NCT05396885RESULTS SAFETY, TOLERABILITY AND CLINICAL ACTIVITY OF ANITO-CEL IN RRMM PDSHAH@LLU.EDU PRANATI SHAH1, NASIM SALIMIAGHDAM2, KARINA BASMAJIAN3, MILAN PATEL4, JEFFREY HU4, KYLE NGUYEN4, MOJTABA AKHTARI1 1 LOMA LINDA UNIVERSITY, LOMA LINDA, CA, USA 2 CAPITAL HEALTH GROUP, TRENTON, NJ, USA 3 ARROWHEAD MEDICAL CENTER, COLTON, CA, USA 4 CREIGHTON UNIVERSITY, PHOENIX, AZ, USA