Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Apr 20, 2026
  • participants needed
    415
  • sponsor
    Celgene
Updated on 22 September 2021
corticosteroids
measurable disease
dexamethasone
bortezomib

Summary

This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM.

The following combinations will be

  • Arm A will test bb2121 in combination with CC-220 ( low-dose dexamethasone)
  • Arm B will test bb2121 in combination with BMS-986405 (JSMD194)
  • Arm C will test bb2121 in combination with one of the following standard triplet regimens: 1) Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (DPd); 2) Pomalidomide (POM) in combination with bortezomib (BTZ) and low-dose dexamethasone (PVd)

Combination agents being tested may be administered before, concurrently with and/or following (ie, maintenance) bb2121 infusion.

The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, multiple myeloma (mm)
Treatment Pomalidomide, Dexamethasone, Bortezomib, bb2121, CC-220, BMS-986405
Clinical Study IdentifierNCT04855136
SponsorCelgene
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must satisfy the following criteria to be enrolled in the study
Participant has documented diagnosis of MM and measurable disease, defined as
M-protein (serum protein electrophoresis [sPEP] or urine protein electrophoresis [uPEP]): sPEP 0.5 g/dL or uPEP 200 mg/24 hours and/or
Light chain MM without measurable disease in the serum or urine: Serum immunoglobulin free light chain 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Participant has received
at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2 and Arm C
Arm A Cohort 1 and Arm B: Participant has received prior treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody-containing regimen for at least 2 consecutive cycles
Arm A Cohort 2 and Arm C: Participant has received prior treatment with an immunomodulatory agent for at least 2 consecutive cycles
Evidence of PD during or within 6 months (measured from the last dose of any drug within the regimen) of completing treatment with the last antimyeloma regimen before study entry
Participant achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

The presence of any of the following will exclude a participant from
enrollment
Participant has non-secretory MM or has history of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis
Participant has any of the following laboratory abnormalities
ANC and Platelets count as reported below
Hemoglobin < 8 g/dL (< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
Creatinine clearance (CrCl) as reported below
Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 upper limit of normal (ULN)
Serum total bilirubin > 1.5 ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome
International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 ULN, or history of Grade 2 hemorrhage within 30 days, or participant requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
Participant has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air
Participant has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
Prior exposure to CC-220 ( low-dose dexamethasone) as part of their most recent antimyeloma treatment regimen (Arm A)
Prior exposure to, BMS-986405 (JSMD194) (Arm B)
Prior exposure to DARA in combination with POM with or without dexamethasone (DPd) as part of their most recent antimyeloma treatment regimen (Arm C Cohort 1)
Prior exposure to POM in combination with BTZ with or without dexamethasone (PV d as part of their most recent antimyeloma treatment regimen (Arm C Cohort 2)
Previous history of an allogeneic hematopoietic stem cell transplantation, treatment with any gene therapy-based therapeutic for cancer, investigational cellular therapy for cancer or BCMA targeted therapy
Treatment Arm A Cohort 1 and Arm B: participant has received autologous stem cell transplantation (ASCT) within 12 weeks prior to leukapheresis
Treatment Arms A Cohort 2 and Arm C: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis
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