Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

This is an open label, abbreviated (3+3) dose escalation study in subjects with RRMM, followed by an extension phase at the selected safe dose. The dose escalation stage will involve recruitment of 3 RRMM patients for 'low' dose (6 x 106 CAR-T cells/kg) CAR-T therapy. After 14 days of follow-up for each of the 3 subjects, the DSC will determine whether the next subject can be recruited. After 14 days follow-up for the 3rd subject, DSC will review data for the 3rd subject and consider the data for the first 3 subjects. In the absence of dose limiting toxicities (DLTs), the DSC may recommend re

Trial Details

NCT ID
NCT05243212
Phase
PHASE1 / PHASE2
Sponsor
Sheba Medical Center
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • CAR-BCMA
Locations (sample)
  • Ramat Gan, Israel|32.08227,34.81065

Key Eligibility Criteria

  • Bone marrow plasma cells must be at least 10% of total bone marrow cells based on a bone marrow biopsy/aspiration performed within 30 days of the s…
  • Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria.
  • Subjects must have measurable MM as defined by at least one of the criteria below.
  • One or more of these abnormalities defines measurable disease

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Multiple Myeloma Trials on Trialify →