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)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Phase 1: To determine the safety and maximum tolerated dose (MTD) of PBCMA101 based on dose limiting toxicities (DLT)
Phase 2: To assess the safety and efficacy of PBCMA101

Secondary Objectives:

The safety and feasibility of P-BCMA-101
The anti-myeloma effect of P-BCMA-101
The effect of cell dose to guide selection of doses for further assessment in Phase 2/3 studies

Eligibility

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).

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices