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New CAR t cocktail aims to tackle Hard-to-Treat myeloma

NCT ID NCT04855136

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Local Institution - 101

    Jacksonville, Florida, 32224-1865, United States

  • Local Institution - 103

    Nashville, Tennessee, 37203, United States

  • Local Institution - 104

    Atlanta, Georgia, 30322, United States

  • Local Institution - 107

    Houston, Texas, 77030, United States

  • Local Institution - 108

    Boston, Massachusetts, 02117, United States

  • Local Institution - 109

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 110

    New York, New York, 10032, United States

  • Local Institution - 111

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 113

    San Francisco, California, 94143, United States

  • Local Institution - 114

    Chicago, Illinois, 60611, United States

  • Local Institution - 117

    Birmingham, Alabama, 10016, United States

  • Local Institution - 118

    Philadelphia, Pennsylvania, 19107, United States

  • Local Institution - 120

    Atlanta, Georgia, 30342, United States

  • Local Institution - 124

    Boston, Massachusetts, 02215, United States

  • Local Institution - 201

    Pamplona, 31008, Spain

  • Local Institution - 202

    Salamanca, 37007, Spain

  • New York University Langone

    New York, New York, 10016, United States

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