anitocabtagene autoleucel (CART-ddBCMA) / Gilead, Kite Pharma - LARVOL DELTA

Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (Anito-Cel) Versus Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed And/or Refractory Multiple Myeloma (RRMM) (IMS 2026) - "Anito -cel showed superior response, and a differentiated safety profile versus TEC and TAL, highlighted by lower odds of any-grade ICANS versus TAL, and high-grade infections/NRM across all comparators, supporting a clinically meaningful benefit–risk advantage compared to BCMA and GPRC5D targeting BsAbs in 4L+ RRMM."

Hematological Malignancies • Infectious Disease • Multiple Myeloma

Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed And/or Refractory Multiple Myeloma (RRMM) (IMS 2026) - "A fter adjusting for clinically relevant prognostic factors, anito‑cel demonstrated no statistically significant differences in ORR or ≥CR rate compared with cilta‑cel but demonstrated a superior safety profile in patients with RRMM treated in the 4L+ setting."

Clinical • CNS Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Parkinson's Disease

Comparison of Adverse Event (AE) Management Costs of Chimeric Antigen Receptor T-Cell (CAR T) Therapies in 4L+ Relapsed And/Or Refractory Multiple Myeloma (RRMM) (IMS 2026) - "The objective of this study was to model total per-patient AE management costs of anito-cel, cilta-cel, and ide-cel in 4L+ RRMM from a US health system perspective. In this analysis, anito-cel was associated with the lowest per-patient AE management costs compared with other CAR T therapies in 4L+ RRMM, driven by differences in incidence of high-cost AEs. Findings should be interpreted in the context of cost estimation assumptions and unadjusted cross-trial comparisons, which may also reflect evolving clinical and management practices over time. Overall, these findings highlight the importance of considering safety-related costs alongside clinical outcomes when evaluating CAR T therapies in RRMM."

Adverse events • CAR T-Cell Therapy • Acute Myelogenous Leukemia • CNS Disorders • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Movement Disorders • Multiple Myeloma • Myelodysplastic Syndrome • Parkinson's Disease

Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (Anito-Cel) Versus Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM) (IMS 2026) - "Anito -cel showed superior response, and a differentiated safety profile versus TEC and TAL, highlighted by lower odds of any-grade ICANS versus TAL, and high-grade infections/NRM across all comparators, supporting a clinically meaningful benefit–risk advantage compared to BCMA and GPRC5D targeting BsAbs in 4L+ RRMM."

Hematological Malignancies • Infectious Disease • Multiple Myeloma

Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM) (IMS 2026) - "A fter adjusting for clinically relevant prognostic factors, anito‑cel demonstrated no statistically significant differences in ORR or ≥CR rate compared with cilta‑cel but demonstrated a superior safety profile in patients with RRMM treated in the 4L+ setting."

Clinical • CNS Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Parkinson's Disease

The D-Domain BCMA CAR-T, Anitocabtagene Autoleucel (Anito-cel), Enables Deep Responses, Favorable Safety, and Efficient Manufacturing (IMS 2026) - No abstract available

CAR T-Cell Therapy • Clinical

Phase 1 Study of Anito-cel, a d-Domain BCMA CAR T Cell for Refractory or Recurrent Myeloma. (PubMed, N Engl J Med) - P1 | "Anito-cel therapy led to a high incidence of response among patients with heavily pretreated relapsed or refractory multiple myeloma. Cytokine release syndrome and ICANS of grade 3 or higher were rare. (Funded by Arcellx and Kite, a Gilead company; ClinicalTrials.gov number, NCT04155749.)."

Journal • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Anito-cel for Multiple Myeloma. (PubMed, N Engl J Med) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Long-term safety and efficacy of BCMA-directed CAR T-cell therapies in multiple myeloma: comparative insights from Cilta-cel, Ide-cel, Anito-cel, and FCARH143. (PubMed, Transl Cancer Res) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 Study of CART-Ddbcma for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-Year Follow-up in All Patients (ASH 2023) - "Briefly, pts with RRMM who have received ≥3 prior lines of therapy were enrolled & received a single infusion of CART-ddBCMA following lymphodepletion chemotherapy (fludarabine: 30 mg/m2/d & cyclophosphamide: 300 mg/m2/d daily for 3 days). Adverse events with CART-ddBCMA, including CRS & ICANS, were manageable & no off-tumor tissue-targeted toxicity, delayed neurotoxicity, or Parkinsonian-like events were observed in the entire cohort at the time of data-cut. Ongoing efficacy results are encouraging, with 100% ORR, including 35 (92%) response of VGPR or better & 29 (76%) with CR/sCR. More importantly, clinical responses were durable with an overall estimated 18-mo PFS rate of 67% with comparable clinical responses seen in 'high-risk' patients known to have poor prognosis."

Clinical • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

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 (ASH 2024) - P2, P3 | "Methods : Pts with RRMM who had received ≥3 prior lines of therapy (LoT) were enrolled and received a single infusion of anito-cel following lymphodepletion chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 daily for 3 days). Follow-up is continuing and updated data will be presented. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498)."

Clinical • P1 data • CNS Disorders • Complement-mediated Rare Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

Safety, Tolerability, and Clinical Activity of Anitocabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma (SOHO 2026) - "Patients received a single infusion of anito-cel following standard lymphodepletion (fludarabine and cyclophosphamide). 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."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

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 (ASH 2024) - P2 | "Following leukapheresis, optional bridging, and anito-cel manufacturing, pts received lymphodepletion chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells). 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."

Clinical • IO biomarker • P2 data • Anemia • CNS Disorders • Complement-mediated Rare Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Neutropenia • Oncology • Parkinson's Disease • Thrombocytopenia

Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma. (ASCO 2022) - P1 | "Pts receive fludarabine and cyclophosphamide (30/300 mg/m2/day) days -5 to -3 and CART-ddBCMA infusion on day 0. CART-ddBCMA administration, to date, has demonstrated clinical activity, including 100% ORR with rates of CR/sCR and ≥VGPR of 67% and 88%, respectively. Durable responses beyond 18 months have been observed, including in pts with EMD."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

CART-ddBCMA for multiple myeloma: Interim results from phase I study (ESMO 2022) - P1 | "Median duration of response, PFS & OS were not evaluable at the time of data-cut because 19 of 24 evaluable pts (79%) remain in ongoing response. Conclusions CART-ddBCMA has demonstrated clinical activity, including 100% ORR & durable responses."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. (PubMed, Blood Adv) - P1 | "Responses deepened over time and at the time of last data-cut (median follow-up 56 weeks), 8/9 (89%) of evaluable patients achieved minimal residual disease negativity. In conclusion, the findings demonstrate the safety of CART-ddBCMA cells and document durable responses to CART-ddBCMA in RRMM patients."

Journal • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • Plasmacytoma

PHASE 1 STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR THE TREATMENT OF PATIENTS WITH RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA: RESULTS FROM AT LEAST 1-YEAR FOLLOW-UP IN ALL PATIENTS (EHA 2024) - "Adverse events with anito-cel, including CRS & ICANS, were manageable; no off-tumor tissue-targeted toxicity,delayed neurotoxicity or Parkinsonian-like events were observed at time of data-cut. Efficacy analysesdemonstrated 100% ORR, including 92% with VGPR or better & 76% with CR/sCR. Clinical responses weredurable with an overall estimated 24-mo PFS rate of 56% with comparable responses seen in pts with 'high-risk' disease characteristics."

Clinical • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

Phase 1 Study Of Anitocabtagene Autoleucel For The Treatment Of Patients With Relapsed And/Or Refractory Multiple Myeloma: Results From At Least 1-year Follow-up In All Patients (IMW 2024) - "Adverse events with anito-cel, including CRS & ICANS, were manageable; no off-tumor tissue-targeted toxicity, delayed neurotoxicity nor Parkinsonian-like events were observed at time of data-cut. Efficacy analyses demonstrated 100% ORR, including 92% with VGPR or better & 76% with CR/sCR. Clinical responses were durable with an overall estimated 24-mo PFS rate of 56% with comparable responses seen in pts with 'high-risk' disease characteristics."

Clinical • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

PHASE 2 REGISTRATIONAL STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA (RRMM): UPDATED RESULTS FROM IMMAGINE-1 (EHA 2025) - P2 | "Ongoing preliminary results from the Phase 2 iMMagine-1 trial demonstrate deep and durable efficacy and manageable safety in a high-risk 4L+ RRMM population. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed across the Phase 1 or Phase 2 iMMagine-1 studies to date. Updated data including efficacy and safety in all treated pts will be presented."

IO biomarker • P2 data • Anemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Neutropenia • Oncology • Parkinson's Disease • Thrombocytopenia

Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine--1 (ASH 2025) - P1, P2 | "Ongoing results from the Phase 2 iMMagine-1 trial demonstrate deep and durable efficacyand manageable safety in a heavily pre-treated, refractory 4L+ RRMM population. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome,and no IEC-associated enterocolitis have been observed across the Phase 1 or Phase 2 iMMagine-1studies to date. Updated data including safety and efficacy outcomes in all patients at a later data cut-offdate will be presented."

Clinical • IO biomarker • P2 data • CNS Disorders • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Movement Disorders • Multiple Myeloma • Neutropenia • Parkinson's Disease • Thrombocytopenia

Nonrelapse Mortality Across Anito-cel and Other BCMA-Targeted Therapies in Relapsed/Refractory Multiple Myeloma: A Systematic Reviewand Meta-Analysis (SOHO 2026) - "All treatments were associated with significantly higher NRM than anito-cel: cilta-cel (OR, 4.42; 95% CI, 1.24–15.71), ide-cel (OR, 4.05; 95% CI, 1.13–14.50), elranatamab (OR, 5.36; 95% CI, 1.27–22.56), and teclistamab (OR, 4.24; 95% CI, 1.08–16.69). In these meta-regressions of BCMA-targeted therapies for RRMM, anito-cel demonstrated significantly lower nonrelapse mortality than did all comparators after heterogeneity adjustments. These analyses leverage a broad evidence base, enabling more generalizable assessment of safety across therapies. Findings indicate meaningful safety differentiation among BCMA-targeted therapies, with infections as a key driver of NRM."

Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Anitocabtagene autoleucel: PDUFA action date for multiple myeloma on Dec 23, 2026 (Gilead) - Q2 2026 Results: FDA decision for 4L+ r/r multiple myeloma (based on iMMagine-1 trial) in H2 2026

FDA approval • PDUFA • Hematological Malignancies • Multiple Myeloma • Oncology

iMMagine-3: A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=452 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

ANITOCABTAGENE AUTOLEUCEL CLINICAL TRIAL MANUFACTURING EXPERIENCE IN PATIENTS WITH RELAPSED/REFRACTORY OR NEWLY DIAGNOSED MULTIPLE MYELOMA (EHA 2026) - "The anito-cel CAR T-cell therapy manufacturing process has been optimized by leveraging the learnings from the robust development process of another CAR T-cell therapy, axicabtagene ciloleucel (axi-cel). Reused with permission. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting."

Clinical • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Anitocabtagene autoleucel (anito-cel) clinical trial manufacturing experience in patients with relapsed/refractory (RR) or newly diagnosed (ND) multiple myeloma (MM). (ASCO 2026) - P2, P3 | "Our results demonstrate rapid and reliable anito-cel manufacturing for MM clinical trials globally, with high manufacturing success rates and consistent turnaround times. These results were consistent with axi-cel manufacturing outcomes and highlight the importance of leveraging axi-cel manufacturing experience in the development of anito-cel."

Clinical • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma