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Comparing a new CAR-T therapy to standard treatment for multiple myeloma

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Phase 3 Interventional Gilead Sciences · NCT06413498

This study tests a new CAR-T therapy to see if it works better than standard treatment for people with multiple myeloma who haven't responded to previous therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionscyclophosphamide, fludarabine, prednisone
Locations124 sites (Gilbert, Arizona and 123 other locations)
Trial IDNCT06413498 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of anitocabtagene autoleucel, a CAR-T cell therapy, compared to standard of care therapy in patients with relapsed or refractory multiple myeloma who have undergone 1 to 3 prior treatments. Participants will be monitored for progression-free survival, with assessments conducted by an independent review committee. Following treatment, participants will enter a long-term follow-up phase to track outcomes over 15 years.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including specific immunomodulatory drugs and anti-CD38 monoclonal antibodies.

Not a fit: Patients who have not received prior treatment or those with early-stage multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promising results with CAR-T therapies in hematological malignancies, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Documented historical diagnosis of multiple myeloma (MM)
* Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
* Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
* Measurable disease at screening per IMWG, defined as any of the following:

  * Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  * Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
* Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Key Exclusion Criteria:

* Prior B-cell maturation antigen (BCMA)-targeted therapy
* Prior T-cell engager therapy
* Prior CAR therapy or other genetically modified T-cell therapy
* Active or prior history of central nervous system (CNS) or meningeal involvement of MM
* Cardiac atrial or cardiac ventricular MM involvement
* History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
* Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
* Prior auto-SCT within 12 weeks before randomization
* Prior allogeneic stem cell transplant (allo-SCT)
* High-dose (eg, cumulative \> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
* Live vaccine ≤ 4 weeks before randomization
* Contraindication to fludarabine or cyclophosphamide
* History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
* Life expectancy \< 12 weeks

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Gilbert, Arizona and 123 other locations

+74 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaCAR-TddBCMABCMA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.