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

  • Interventional
  • Not Recruiting
  • NCT03288493
Eligibility Details Visit Clinicaltrials.gov

Open-Label, Multicenter, Single Ascending Dose Study to Assess the Safety of P-BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)

A Phase 1, open-label, single ascending dose (SAD) 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 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 containing a two arm cycle dosing regime. 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. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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.

At a Glance

National Government IDNCT03288493


Lead SponsorPoseida Therapeutics, Inc.

Lead PhysicianAndrzej Jakubowiak


18 Years and up
Not Recruiting