P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring CAR-T cells
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).
Sites / Locations
- Banner MD Anderson Cancer Center
- University of California Davis
- University of California San Diego
- University of California San Francisco
- Colorado Blood Cancer Institute
- University of Chicago
- University of Kansas Cancer Center
- University of Maryland Greenebaum Comprehensive Cancer Center
- Johns Hopkins University
- Wayne State - Karmanos Cancer Institute
- John Theurer Cancer Center
- University of Pennsylvania
- Sarah Cannon Research Institute at Tennessee Oncology
- Vanderbilt University Medical Center
- MD Anderson Cancer Center
- Swedish Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Phase 1: P-BCMA-101 CAR-T cells
Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
Phase 1 P-BCMA-101 CAR-T cells (Cohort B)
Phase 1 P-BCMA-101 CAR-T cells (Cohort C)
Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)
Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)
Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)
Phase 2: P-BCMA-101 CAR-T Cells
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
CAR-T cells administered via intravenous infusion as a total dose