Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
NCT ID: NCT04855136
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2021-06-01
2025-04-25
Brief Summary
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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)
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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)
bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.
BB2121
CAR T Cell Therapy
CC-220
Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
Arm B- bb2121 in combination with BMS-986405 (JSMD194)
* bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion
* Enrollment is closed for this Arm
BB2121
CAR T Cell Therapy
BMS-986405
gamma secretase inhibitor (GSI)
Interventions
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BB2121
CAR T Cell Therapy
CC-220
Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
BMS-986405
gamma secretase inhibitor (GSI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has documented diagnosis of MM and measurable disease, defined as:
1. M-protein (serum protein electrophoresis \[sPEP ≥ 0.5 g/dL\] or urine protein electrophoresis \[uPEP\]): uPEP ≥ 200 mg/24 hours and/or
2. 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:
1. at least 3 prior MM regimens for Arm A Cohort 1 and Arm B
2. at least 1 but no greater than 3 prior MM regimens for Arm A Cohort 2
* 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: 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
* 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:
1. ANC and Platelets count as reported below
2. Hemoglobin \< 8 g/dL (\< 4.9 mmol/L) (transfusion is not permitted within 21 days of screening)
3. Creatinine clearance (CrCl) as reported below
4. Corrected serum calcium \> 13.5 mg/dL (\> 3.4 mmol/L)
5. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 ×upper limit of normal (ULN)
6. Serum total bilirubin \> 1.5 × ULN or \> 3.0 mg/dL for participants with documented Gilbert's syndrome
7. 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).
* 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 Arm A Cohort 2: participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 117
Birmingham, Alabama, United States
Local Institution - 113
San Francisco, California, United States
Local Institution - 101
Jacksonville, Florida, United States
Local Institution - 104
Atlanta, Georgia, United States
Local Institution - 120
Atlanta, Georgia, United States
Local Institution - 114
Chicago, Illinois, United States
Local Institution - 108
Boston, Massachusetts, United States
Local Institution - 124
Boston, Massachusetts, United States
Local Institution - 109
Hackensack, New Jersey, United States
New York University Langone
New York, New York, United States
Local Institution - 110
New York, New York, United States
Local Institution - 111
Charlotte, North Carolina, United States
Local Institution - 118
Philadelphia, Pennsylvania, United States
Local Institution - 103
Nashville, Tennessee, United States
Local Institution - 107
Houston, Texas, United States
Local Institution - 201
Pamplona, , Spain
Local Institution - 202
Salamanca, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-003248-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BB2121-MM-007
Identifier Type: -
Identifier Source: org_study_id
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