P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
- Interventional
- Recruiting
- NCT03288493
Contact Information
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 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.
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.
- 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).
- 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).