arlocabtagene autoleucel (BMS-986393) / BMS - LARVOL DELTA

Post-Infusion Immunophenotypic and Functional Characteristics of Arlocabtagene Autoleucel (Arlo-Cel) in a First-In-Human (FiH), Phase 1 Trial in Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - P1 | "Arlo-cel phenotypic and functional characteristics suggest early anti-tumor activity, memory formation within the CD4+ CAR T cells, and resolution of the inflammatory state after tumor clearance. Early arlo-cel activation, proliferation, and supportive cytokine production mediate tumor eradication. After tumor clearance, memory evolution in the CD4+ CAR T compartment may support arlo-cel anti-MM surveillance, while resolution of inflammation may indicate target specific arlo-cel activity."

First-in-human • IO biomarker • P1 data • Hematological Malignancies • Multiple Myeloma • CD27 • CD4 • CD8 • CSF2 • IFNG • IL12A • IL15 • IL2 • IL6

Trial in Progress: Phase 1 Trial of Arlocabtagene Autoleucel (Arlo-Cel) Plus Mezigdomide (MEZI) or Elranatamab (ELRA) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - P1 | "This trial will evaluate arlo-cel combinations, including with MEZI and ELRA maintenance, in RRMM."

Clinical • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • IKZF1

Post-Infusion Immunophenotypic and Functional Characteristics of Arlocabtagene Autoleucel (Arlo-Cel) in a First-in-Human (FiH), Phase 1 Trial in Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - P1 | "Arlo-cel phenotypic and functional characteristics suggest early anti-tumor activity, memory formation within the CD4+ CAR T cells, and resolution of the inflammatory state after tumor clearance. Early arlo-cel activation, proliferation, and supportive cytokine production mediate tumor eradication. After tumor clearance, memory evolution in the CD4+ CAR T compartment may support arlo-cel anti-MM surveillance, while resolution of inflammation may indicate target specific arlo-cel activity."

First-in-human • IO biomarker • P1 data • Hematological Malignancies • Multiple Myeloma • CD27 • CD4 • CD8 • CSF2 • IFNG • IL12A • IL15 • IL2 • IL6

Trial in Progress: QUINTESSENTIAL-2, a Phase 3 Study of Arlocabtagene Autoleucel vs Standard of Care in Adult Patients With Relapsed/Refractory Multiple Myeloma Exposed to Lenalidomide (SOHO 2026) - P3 | "Context: Despite advances in multiple myeloma (MM) treatment, most patients will relapse, highlighting the need for new drug classes in relapsed/refractory MM (RRMM). Reused with permission. BCMA: B-cell maturation antigen, CD: cluster of differentiation, CR: complete response, DPd: daratumumab, pomalidomide, and dexamethasone, ECOG: Eastern Cooperative Oncology Group, IMiD: immunomodulatory drug, IMWG: International Myeloma Working Group, Kd: carfilzomib and dexamethasone, MRD: minimal residual disease, OS: overall survival, PFS: progression-free survival, SOC: standard of care."

Clinical • First-in-human • IO biomarker • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and preliminary efficacy of BMS-986393, a GPRC5D CAR T cell therapy, in patients (pts) with relapsed/refractory (RR) multiple myeloma (MM) and 1–3 prior regimens: results from a phase 1 study (IMW 2024) - P1 | "Around half (52%) had prior stem cell transplantation; 71% had received anti-CD38 therapy; 90% were lenalidomide-refractory; 55% were triple-class refractory; 90% had MM refractory to the last regimen, and 3% had prior B-cell maturation antigen (BCMA)-targeted therapy. Initial results suggest that a single infusion of BMS-986393 is safe and has promising preliminary efficacy in pts with RRMM and 1–3 prior regimens. While follow-up is limited, the safety profile of BMS-986393 at 150 x 106 CAR T cells was favorable with no new safety signals. High response rates were achieved."

CAR T-Cell Therapy • Clinical • P1 data • Ataxia • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Movement Disorders • Multiple Myeloma • Oncology • Rare Diseases

BMS-986393, a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Relapsed/Refractory (RR) Multiple Myeloma (MM) and 1–3 Prior Regimens: Updated Phase 1 Safety and Efficacy Results (ASH 2024) - "Most (90%) had MM refractory to the most recent regimen; 90% had lenalidomide-refractory, 55% triple-class refractory, and 6% penta-class refractory MM. These data support BMS-986393 as a potential early-line treatment in RRMM. The trial is ongoing and a further update with longer follow-up will be presented."

CAR T-Cell Therapy • Clinical • P1 data • Ataxia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Oncology • Rare Diseases

QUINTESSENTIAL: Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Trial primary completion date: Jun 2027 ➔ Jul 2026

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Arlocabtagene autoleucel-a GPRC5D-targeted CAR T-cell therapy in heavily pretreated relapsed/refractory multiple myeloma. (PubMed, Blood) - P1 | "The 1-year OS rate was 90% (N=84). In conclusion, arlo-cel had a safety profile supportive of future study and demonstrated deep and durable responses, with promising PFS and OS in patients with heavily pretreated RRMM."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Skin Cancer

GPRC5D-Targeted Therapies in Relapsed/Refractory Multiple Myeloma: A Systematic Review and Single-Arm Meta-Analysis (SOHO 2026) - " In total, 8 cohorts comprising 549 efficacy-evaluable patients were included: 4 BsAb cohorts from MonumenTAL-1 (talquetamab; N = 405) and 4 CAR-T cohorts (arlocabtagene autoleucel [arlo-cel], MCARH109, OriCAR-017, RD118; N = 124)... GPRC5D-targeted therapies achieve high and deep responses in heavily pretreated RRMM, with a pooled ORRexceeding 80%. CART approaches appear to deliver higher response rates and deeper remissions than BsAb therapy does, although cross-modal comparisons are limited by small CAR-T therapy patient sample sizes and trial heterogeneity. The class-defining on-target toxicity profile—skin, nail, and taste toxicities—is frequent but manageable."

Retrospective data • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety with Extended Follow-up in a Phase 1 Study of BMS-986393, a G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Heavily Pretreated Relapsed/Refractory (RR) Multiple Myeloma (MM) (ASH 2024) - P2 | "These data support BMS-986393 as a potential treatment for heavily pretreated RRMM, which is being investigated in the ongoing phase 2 QUINTESSENTIAL study (NCT06297226). The presentation will report updated data after ~ 18 months' follow-up, including the first overall survival data."

CAR T-Cell Therapy • Clinical • P1 data • Ataxia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Oncology • Ophthalmology • Rare Diseases

BMS-986393 (CC-95266), a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 Study (ASH 2023) - P1 | "In this first-in-human study, BMS-986393 showed a manageable safety profile and deep and durable responses, including MRD negativity, at all tested dose levels, including in pts refractory to prior BCMA-directed therapies. CRS and ICANS-type neurotoxicity were mostly low-grade, with increased G ≥ 3 events at the 300 and 450 × 106 CAR T‑cell doses. On-target off-tumor TRAEs, all G1/2, occurred in a minority of pts."

IO biomarker • P1 data • Anemia • Ataxia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Neutropenia • Oncology • Ophthalmology • Plasmacytoma • Rare Diseases • Thrombocytopenia • GPRC5D

BMS-986393 (CC-95266), A G PROTEIN–COUPLED RECEPTOR CLASS C GROUP 5 MEMBER D (GPRC5D)–TARGETED CAR T-CELL THERAPY FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): RESULTS FROM A PHASE 1 STUDY (EHA 2023) - P1 | "Dose escalation of BMS-986393 from 25 through 450 × 10 6 CAR T cells has not exceeded the MTD at the time of data cutoff. Observed CRS was mostly G1/2. ICANS-type neurotoxicity was infrequent, low-grade, and reversible."

CAR T-Cell Therapy • IO biomarker • P1 data • Anemia • Bone Marrow Transplantation • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immune Modulation • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Thrombocytopenia • Transplantation • GPRC5D

Assessment of normal plasma cell biomarkers after arlocabtagene autoleucel (arlo-cel) treatment in patients with ≥3L relapsed refractory multiple myeloma (MM). (ASCO 2025) - P1, P2 | " Clinical endpoints included treatment-emergent adverse events for patients treated with arlo-cel (NCT04674813; n = 84) and idecabtagene vicleucel (ide-cel, NCT03361748; n = 137). Arlo-cel patients had higher levels of uiFLC from months 2–6, demonstrating greater anti-tumor specificity and preservation of humoral immunity. As a result, arlo-cel has the potential to achieve lower rates of hypogammaglobulinemia and infections compared to BCMA-targeting therapies, with fewer interventions."

Biomarker • Clinical • IO biomarker • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • GPRC5D

BMS-986393 (CC-95266), a G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM): results from a phase 1 study (IMW 2023) - P1 | "As of data cutoff, dose escalation of BMS-986393 from 25–450 × 10⁶ CAR T cells did not exceed MTD. CRS was mostly G1/2. ICANS-type neurotoxicity was infrequent, low-grade and reversible."

CAR T-Cell Therapy • IO biomarker • P1 data • Anemia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Thrombocytopenia • GPRC5D

Clinical Activity of BMS-986393 (CC-95266), a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T Cell Therapy, in Patients with Relapsed and/or Refractory (R/R) Multiple Myeloma (MM): First Results from a Phase 1, Multicenter, Open-Label Study (ASH 2022) - P1 | "After screening and leukapheresis, pts received bridging therapy if needed, then lymphodepleting chemotherapy (fludarabine 30 mg/m2 + cyclophosphamide 300 mg/m2 daily for 3 days) followed by a single infusion of BMS-986393... At all tested dose levels, BMS-986393 demonstrated a favorable safety profile; both CRS and neurotoxicity were low-grade, and neurotoxicity was infrequent and short-lived. Dose escalation is ongoing; MTD has not been exceeded. Preliminary efficacy appeared promising; antitumor responses were observed, including pts with CR who were MRD-negative at month 3."

Clinical • IO biomarker • P1 data • Bone Marrow Transplantation • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Thrombocytopenia • Transplantation • GPRC5D

Next-gen CAR-T from BMS passes pivotal test in quadruple-class exposed myeloma (Firstwordpharma Press Release) - "The results come from the Phase II QUINTESSENTIAL study, which investigated arlo-cel in patients with quadruple-class exposed relapsed and refractory multiple myeloma...Top-line results showed that the trial met its primary endpoint with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in patients with quadruple-class exposed RRMM who had received four or more prior lines of therapy."

P2 data • Multiple Myeloma

Bristol Myers Squibb Announces Positive Topline Results from Registrational Phase 2 QUINTESSENTIAL Trial of the Potential First-in-Class GPRC5D-Directed CAR T Cell Therapy, Arlocabtagene Autoleucel (Bristol-Myers Squibb Press Release) - "Results show the study met its primary endpoint with arlo-cel demonstrating a statistically significant and clinically meaningful overall response rate (ORR) in patients with quadruple-class exposed RRMM who had received four or more prior lines of therapy. Quadruple-class exposed consists of those who had been treated with an immunomodulatory inhibitor (IMiD), a proteasome inhibitor (PI), an anti-CD38 therapy and a BCMA-targeted therapy. The study also met the key secondary endpoint of complete response rate (CRR) in patients with RRMM who had been quadruple-class exposed after four or more prior lines of therapy, and the key secondary endpoints of ORR and CRR after three or more prior lines of therapy....Results from QUINTESSENTIAL will be presented at an upcoming medical meeting."

P2 data • Multiple Myeloma

Arlocabtagene Autoleucel in Patients With Heavily Pretreated Relapsed/Refractory Multiple Myeloma: Final Analysis From the Phase 1 Study (SOHO 2026) - P1 | "Context: Arlocabtagene autoleucel (arlo-cel) is a CAR-T therapy targeting G protein-coupled receptor class C group 5 member D (GPRC5D), a validated target in RRMM. Final results from the first-in-human phase 1 study of arlo-cel represent longest follow-up with GPRC5D CAR T therapy in RRMM and continue to demonstrate deep, durable responses following a single arlo-cel infusion; no new safety signals were observed. Findings support arlo-cel as a safe and effective potential late-line treatment option in RRMM. AEs: adverse events, CAR-T: chimeric antigen receptor T-cell, MM: multiple myeloma, NA: not available, RRMM: relapsed/refractory multiple myeloma, TEAEs: treatment emergent adverse events."

Clinical • First-in-human • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Arlocabtagene Autoleucel, a GPRC5D-Targeted CAR T-Cell Therapy for Patients With Relapsed/Refractory Multiple Myeloma: Updated Phase 1 Safety and Efficacy Results in Patients With 1–3 Prior Regimens (SOHO 2026) - P1, P3 | "A single infusion of arlo-cel in patients with RR MM and 1–3 pLOT was well tolerated and led to a high response rate that deepened over time. Notably, the frequency and grade of infections were lower than those reported for BCMA-targeted therapies. These data support arlo-cel as a safe and effective potential early-line treatment in RRMM, with a phase 3 trial (QUINTESSENTIAL 2; NCT06615479) underway."

CAR T-Cell Therapy • Clinical • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

SAFETY AND PRELIMINARY EFFICACY OF BMS-986393, A GPRC5D CAR T CELL THERAPY, IN PATIENTS WITH RELAPSED/REFRACTORY (RR) MULTIPLE MYELOMA (MM) AND 1–3 PRIOR REGIMENS: FIRST RESULTS FROM A PHASE 1 STUDY (EHA 2024) - P1 | "After leukapheresis, pts received lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed bya single infusion of BMS​986393 150 × 106 CAR T cells...One pt (3%) had a prior BCMA-targeted therapy (belantamab mafodotin)... Initial results suggest a single infusion of BMS-986393 is safe and demonstrates promising preliminary efficacyin pts with MM and 1–3 prior regimens. While follow-up is limited, the safety profile of BMS-986393 at 150 x106 CAR T cells was favorable with no new safety signals. High response rates were achieved."

CAR T-Cell Therapy • Clinical • P1 data • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Rare Diseases • Transplantation

ARLOCABTAGENE AUTOLEUCEL, A GPRC5D-TARGETED CAR T-CELL THERAPY FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: UPDATED PHASE 1 SAFETY AND EFFICACY RESULTS IN PATIENTS WITH 1–3 PRIOR REGIMENS (EHA 2026) - P1, P3 | "Notably, frequency and grade of infections were lower than those reported for BCMA-targeted therapies. These data support arlo-cel as a safe and effective potential early-line treatment in RRMM, with a phase 3 trial (QUINTESSENTIAL 2; NCT06615479) underway."

CAR T-Cell Therapy • Clinical • P1 data • Ataxia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Movement Disorders • Multiple Myeloma • Rare Diseases

Trial in progress: QUINTESSENTIAL-2—a phase 3 study of arlocabtagene autoleucel versus standard of care in adult patients with relapsed and refractory multiple myeloma (RRMM) exposed to lenalidomide (ASH 2025) - P3 | "Eligible pts will berandomized 1:1 to Arm A or Arm B. Pts randomized to Arm A will have leukapheresis within 3-4 days ofrandomization, bridging therapy of DPd (daratumumab, pomalidomide, dexamethasone) or Kd(carfilzomib, dexamethasone) per Investigator choice within 6 days of randomization, andlymphodepleting chemotherapy prior to a single infusion of arlo-cel. This is a trial in progress and isexpected to enroll 440 pts at ~126 sites globally across North America, South America, Europe, Asia, andAustralia. The first patient was enrolled in March 2025."

Clinical • IO biomarker • P3 data • Hematological Malignancies • Multiple Myeloma

TRIAL IN PROGRESS: QUINTESSENTIAL-2—A PHASE 3 STUDY OF ARLOCABTAGENE AUTOLEUCEL VERSUS STANDARD OF CARE IN ADULT PATIENTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM) EXPOSED TO LENALIDOMIDE (EHA 2026) - P3 | "Arm A includes leukapheresis within 3-4 days of randomization, mandatory bridging therapy ≤6 days of randomization with DPd (daratumumab, pomalidomide, dexamethasone) or Kd (carfilzomib, dexamethasone) per Investigator choice and lymphodepleting chemotherapy prior to a single arlo-cel infusion."

Clinical • First-in-human • IO biomarker • P3 data • Hematological Malignancies • Multiple Myeloma

QUINTESSENTIAL-2: A phase 3 study of arlocabtagene autoleucel versus standard of care in adult patients with relapsed and refractory multiple myeloma (RRMM) exposed to lenalidomide. (ASCO 2026) - P3 | "Arm A includes leukapheresis within 3-4 days of randomization, mandatory bridging therapy ≤6 days of randomization with DPd (daratumumab, pomalidomide, dexamethasone) or Kd (carfilzomib, dexamethasone) per investigator choice and lymphodepleting chemotherapy prior to a single arlo-cel infusion."

Clinical • First-in-human • IO biomarker • P3 data • Hematological Malignancies • Multiple Myeloma

MODULE 1: Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory (R/R) Multiple Myeloma (MM) (ASCO 2026) - "Supported by This activity is supported by educational grants from Bristol Myers Squibb, Genentech, a member of the Roche Group, and GSK. Research database documenting the effectiveness of idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) for patients with heavily pretreated MM Published data from the Phase III KarMMa-3 and CARTITUDE-4 trials of ide-cel and cilta-cel, respectively, in earlier lines of treatment; overall survival findings from CARTITUDE-4 FDA approvals of ide-cel and cilta-cel in earlier settings; identification of patients appropriate for CAR T-cell therapy and optimal sequencing with regard to other evidence-based approaches Spectrum, incidence and severity of acute and long-term toxicities with BCMA-directed CAR T-cell therapy in patients with MM; appropriate monitoring and management algorithms Rationale for the evaluation of CAR T-cell platforms with novel targets and/or manufacturing processes for R/R MM Early data with the..."

Hematological Malignancies • Multiple Myeloma