Title

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Open-Label, Multicenter, Phase 1 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)
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Terminated
  • Study Participants

    105
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 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.
Study Started
Sep 20
2017
Primary Completion
Apr 27
2022
Study Completion
Apr 27
2022
Last Update
May 24
2022

Biological P-BCMA-101 CAR-T cells

P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.

Drug Rimiducid

Rimiducid (safety switch activator) may be administered as indicated.

Phase 1: P-BCMA-101 CAR-T cells Experimental

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells (Cohort A) Experimental

Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells (Cohort B) Experimental

Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells (Cohort C) Experimental

Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R) Experimental

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP) Experimental

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT) Experimental

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

Phase 2: P-BCMA-101 CAR-T Cells Experimental

CAR-T cells administered via intravenous infusion as a total dose

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).
No Results Posted