BMS-986354 / BMS - LARVOL DELTA

Effect of Prior Selinexor Exposure on Clinical Outcomes of Chimeric Antigen Receptor T-cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM): A Real-World Descriptive Analysis (IMW 2024) - "The CAR-T products given included idecabtagene vicleucel (60%), ciltacabtagene autoleucel (35.6%), and BMS-986354 (4.4%)...The most common selinexor-based regimens were selinexor+bortezomib+dexamethasone (28.9%) and selinexor+carfilzomib+dexamethasone (20%), with 75.6% of patients starting selinexor at a dose ≤ 80 mg and 24.4% at dose ≥ 100mg... In this retrospective analysis, CAR-T clinical outcomes in heavily pretreated RRMM were unaffected by prior selinexor treatment. Further studies are warranted to examine the effect of specific selinexor combinations on clinical outcomes, including promoting an anti-tumor immune microenvironment, particularly pre-, post- and in-between CAR-T and other T-cell engaging regimens."

CAR T-Cell Therapy • Clinical • Clinical data • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Survival Analysis of Selinexor-Exposed Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Chimeric Antigen Receptor T-Cell (CAR-T) Therapy: A Real-World Exploratory Analysis (IMW 2024) - "CAR-T therapies used consisted of idecabtagene vicleucel (60%), ciltacabtagene autoleucel (35.6%), and BMS-986354 (4.4%). When compared to those with a more distant exposure to selinexor, patients with RRMM treated with a selinexor-based regimen in the LOT immediately prior to CAR-T therapy experience improved survival outcomes. Further investigation with a larger real-world cohort including patients from other centers or a prospective clinical trial is warranted to confirm any survival benefit."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology • XPO1

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Juno Therapeutics, a Subsidiary of Celgene | Active, not recruiting ➔ Completed | N=150 ➔ 78 | Trial completion date: Jun 2025 ➔ Jul 2024 | Trial primary completion date: Jun 2025 ➔ Jul 2024

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

Results from the First Phase 1 Clinical Study of the B-Cell Maturation Antigen (BCMA) Nex T Chimeric Antigen Receptor (CAR) T Cell Therapy CC-98633/BMS-986354 in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM) (ASH 2022) - P1 | "Pts received a single BMS-986354 infusion 2–7 days after lymphodepleting chemotherapy (3 days fludarabine [30 mg/m2] and cyclophosphamide [300 mg/m2])...Median onset was day 4 (range, 2–8), median duration was 4 days (range, 1–8), and common treatments included tocilizumab (n = 38), steroids (n = 25), and anakinra (n = 9)... BMS-986354, a NEX-T investigational BCMA-targeted CAR T-cell product, is a less differentiated, more potent cellular drug product than orva-cel and can be manufactured with a more rapid processing time. At low doses, BMS-986354 demonstrated a favorable safety profile and promising efficacy, including deep and durable responses in pts with heavily pretreated RRMM. The study continues to enroll patients in the dose-expansion phase."

Clinical • P1 data • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • Transplantation • IFNG • IL2 • TNFA

[VIRTUAL] Multiple Myeloma (MM) (ASCO 2021) - "Biologic rationale for targeting the B-cell maturation antigen (BCMA) with CAR T-cell therapy for MM Compositional and mechanistic similarities and differences among various BCMA-targeted CAR T-cell platforms under investigation for MM Design, eligibility criteria and available efficacy and safety results from the pivotal Phase II KarMMa trial of idecabtagene vicleucel for patients with R/R MM; recent FDA approval and optimal integration into treatment algorithms Clinical, biologic and pathologic factors in the selection of patients with MM for treatment with CAR T-cell therapy Updated results from the CARTITUDE-1, EVOLVE and CRB-402 trials of ciltacabtagene autoleucel, orvacabtagene autoleucel and bb21217, respectively, for patients with R/R MM Incidence, timing and severity of adverse events associated with BCMA-directed CAR T-cell therapies for MM; optimal monitoring and management strategies Other promising CAR T-cell platforms under investigation in MM (eg,..."

Hematological Malignancies • Multiple Myeloma • Oncology

CAR-T BMS-986354 | Luciano Costa, MD, PhD | ASH 2022 (YouTube) - "Interview with Luciano Costa, MD, PhD...at ASH 2022. Filmed December 11, 2022."

Interview • Video

Phase 1 Clinical Study of the BCMA Nex T CAR T Cell Therapy CC-98633/BMS-986354 in pts with RRMM (YouTube) - "Dr. Luciano Costa...presents the results of the first phase 1 clinical study of the B-Cell Maturation Antigen (BCMA) Nex T Chimeric Antigen Receptor (CAR) T Cell therapy CC-98633/BMS-986354 in patients with Relapsed/Refractory Multiple Myeloma (RRMM)."

Video

"The BCMApalooza continues: $BMY CC-98633/BMS-986354, Car-T based on Juno-derived orva-cel (not Bluebird Abecma) #ASH22" (@JacobPlieth)

"#ash22 #mmsm further slides on CC 98633 BMS 986354 https://t.co/xBIS4R2THQ" (@profghjackson)

Hematological Malignancies • Multiple Myeloma

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=150 | Active, not recruiting | Sponsor: Juno Therapeutics, a Subsidiary of Celgene | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Juno Therapeutics, a Subsidiary of Celgene | N=80 ➔ 150 | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

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

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Juno Therapeutics, a Subsidiary of Celgene | Trial completion date: Nov 2023 ➔ Jul 2024 | Trial primary completion date: Nov 2023 ➔ Jul 2024

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

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Juno Therapeutics, a Subsidiary of Celgene; Trial completion date: Jan 2025 ➔ Nov 2023; Trial primary completion date: Jan 2025 ➔ Nov 2023

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

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Juno Therapeutics, a Subsidiary of Celgene; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Juno Therapeutics, a Subsidiary of Celgene

Clinical • New P1 trial • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology