New CAR t cocktail aims to tackle Hard-to-Treat myeloma
NCT ID NCT04855136
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This early-phase trial tested a CAR T cell therapy called bb2121 (ide-cel) combined with other drugs in 21 adults with relapsed or refractory multiple myeloma. The goal was to find a safe dose and see if the combinations could shrink tumors. The study was terminated early, so results are limited, but it provides initial safety and effectiveness data for these combination approaches.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bb2121 (ide-cel) CAR T cell therapy combined with CC-220 or BMS-986405
- What this could lead to
- If successful, this could point toward a more effective treatment option for patients with multiple myeloma that has stopped responding to other therapies.
- What could go wrong
- This is an early, small trial (21 participants) that was terminated, so results are limited. CAR T therapy carries risks like severe immune reactions and may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Jun 2021
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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: 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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Local Institution - 101
Jacksonville, Florida, 32224-1865, United States
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Local Institution - 103
Nashville, Tennessee, 37203, United States
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Local Institution - 104
Atlanta, Georgia, 30322, United States
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Local Institution - 107
Houston, Texas, 77030, United States
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Local Institution - 108
Boston, Massachusetts, 02117, United States
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Local Institution - 109
Hackensack, New Jersey, 07601, United States
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Local Institution - 110
New York, New York, 10032, United States
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Local Institution - 111
Charlotte, North Carolina, 28204, United States
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Local Institution - 113
San Francisco, California, 94143, United States
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Local Institution - 114
Chicago, Illinois, 60611, United States
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Local Institution - 117
Birmingham, Alabama, 10016, United States
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Local Institution - 118
Philadelphia, Pennsylvania, 19107, United States
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Local Institution - 120
Atlanta, Georgia, 30342, United States
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Local Institution - 124
Boston, Massachusetts, 02215, United States
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Local Institution - 201
Pamplona, 31008, Spain
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Local Institution - 202
Salamanca, 37007, Spain
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New York University Langone
New York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?