P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)

Poseida Therapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Multiple Myeloma

Treatments

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03288493

P-BCMA-101-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

105 participants in 8 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

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

Experimental group

Description:

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

Treatment:

Biological: P-BCMA-101 CAR-T cells

Drug: Rimiducid

Trial documents