Status:
TERMINATED
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Lead Sponsor:
Poseida Therapeutics, Inc.
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-B...
Detailed Description
Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obt...
Eligibility Criteria
Inclusion
- 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 proteasome inhibitor and IMiD \[Phase 2: Must have relapsed / refractory MM, and refractory to last line of therapy, having received treatment with proteasome inhibitor, an IMiD, CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a candidate for ASCT.\]
- Must have adequate hepatic, renal, cardiac and hematopoietic function
Exclusion
- Is pregnant or lactating
- Has inadequate venous access and/or contraindications to leukapheresis
- Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis, significant autoimmune, CNS or other malignant disease
- 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 hepatitis B or C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome.
- Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
- Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry
- Has CNS metastases or symptomatic CNS involvement
- 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.
- Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. (Cohorts R and RP only).
- History of thromboembolic disease within the past 6 months, regardless of anticoagulation (Cohorts R and RP only).
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03288493
Start Date
September 20 2017
End Date
April 27 2022
Last Update
March 28 2024
Active Locations (16)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
University of California Davis
Davis, California, United States, 95618
3
University of California San Diego
San Diego, California, United States, 92093
4
University of California San Francisco
San Francisco, California, United States, 94143