P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
18 Years and older, Male and Female
P-BCMA-ALLO1-001 (primary)
NCI-2022-02554
Summary
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1
allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory
Multiple Myeloma (RRMM).
Objectives
Phase 1/1b study: Phase 1 Part 1 is a weight-based dose escalation following a 3+3 design
of dose-escalating cohorts. Phase 1 Part 2 includes administration at fixed doses. After
enrollment, subjects may receive a lymphodepletion therapy regimen before administration
of allogeneic CAR-T cells, administered as a single or multiple dose(s). Treated subjects
will undergo serial measurements of safety, tolerability and response. Rimiducid may be
administered as indicated. Phase 1b of the study will undergo further expansion of
cohorts/arms from Phase 1 Parts 1 or 2 or an intermediate dose between cohort levels.
Eligibility
- Must have signed written, informed consent.
- Males or females, =18 years of age.
- Must have a confirmed diagnosis of active MM.
- Must have measurable MM.
- Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
- Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
- Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential).
- Must be at least 90 days since autologous stem cell transplant, if performed.
- Must have adequate vital organ function within pre-determined parameters.
- Must have recovered from toxicities due to prior therapies.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Treatment Sites in Georgia
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