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

Recruiting Phase 1 Phase 2 Interventional Study
Multiple Myeloma Relapse Multiple Myeloma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Sheba Medical Center · Government
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 start of protocol treatment. 2. Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria. 3. Subjects must h…
Contacts

Hila Magen, MD

+97235308176

Hila.magen@sheba.health.gov.il

CONTACT