Multiple Myeloma Clinical Trial

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)

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-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.

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Full 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 obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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).

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

105

Study ID:

NCT03288493

Recruitment Status:

Terminated

Sponsor:

Poseida Therapeutics, Inc.

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There are 16 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
University of California Davis
Davis California, 95618, United States
University of California San Diego
San Diego California, 92093, United States
University of California San Francisco
San Francisco California, 94143, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
University of Chicago
Chicago Illinois, 60637, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Johns Hopkins University
Baltimore Maryland, 21231, United States
Wayne State - Karmanos Cancer Institute
Detroit Michigan, 48201, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

105

Study ID:

NCT03288493

Recruitment Status:

Terminated

Sponsor:


Poseida Therapeutics, Inc.

How clear is this clinincal trial information?

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