P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
a study on Multiple Myeloma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startestimated completion
Description
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).
Official Title
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
Details
Phase 1 study consisting of two parts. Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts. 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 doses. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
Keywords
Multiple Myeloma, Plasma Cell Neoplasms, P-BCMA-ALLO1 CAR-T cells, Rimiducid, P-BCMA-ALLO1 CAR-T cells (Arm160), P-BCMA-ALLO1 CAR-T cells (Arm480)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
10. Must have recovered from toxicities due to prior therapies. 11. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
You CAN'T join if...
- Is pregnant or lactating.
- Has inadequate venous access.
- Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
- Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma.
- Has active autoimmune disease.
- Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc.
- Has an active systemic infection.
- Has a history of hepatitis B, hepatitis C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by Hepatitis C PCR on multiple occasions and with medical monitor approval.
Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia.
10. Has any psychiatric or medical disorder that would preclude safe participation in
and/or adherence to the protocol.
11. Has received prior allogeneic cellular therapy or gene therapy. 12. Has received anti-cancer medications within 2 weeks of the time of initiating
conditioning LD therapy.
13. Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD
therapy.
14. Has received immunosuppressive medications within 2 weeks of the time of
administration of P-BCMA-ALLO1, and/or expected to require them while on study.
15. Has received systemic corticosteroid therapy within 1 week or 5 half-lives (whichever
is shorter) of the administration of P-BCMA-ALLO1 or is expected to require it during the course of the study.
16. Has CNS metastases or symptomatic CNS involvement of their myeloma. 17. Has a history of severe immediate hypersensitivity reaction to any of the agents used
in this study.
18. Has a history of having undergone allogeneic stem cell transplantation, or any other
allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.
19. Arms R and RS Only: a) Has received a live vaccine within the last 28 days of the
first administration of agents used in Arm R or RS, b) Has any known hypersensitivity or severe reactions or toxicity to agents used in Arms R or RS.
Locations
- University of California San Diego
accepting new patients
San Diego California 92093 United States - University of California San Francisco
terminated
San Francisco California 94143 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Poseida Therapeutics, Inc.
- ID
- NCT04960579
- Phase
- Phase 1 Multiple Myeloma Research Study
- Study Type
- Interventional
- Participants
- Expecting 135 study participants
- Last Updated
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