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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poseida Therapeutics, Inc.
• Collaborator: California Institute for Regenerative Medicine (CIRM)

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).