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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

IRB#IRB19-0335

Lead SponsorPoseida Therapeutics, Inc.

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting