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

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03288493

Run by

Poseida Therapeutics, Inc.

People needed

105

Starts

2017-09-20

Expected to finish

2022-04-27

Last updated by the study team

2024-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of California Davis — Davis, California, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Wayne State - Karmanos Cancer Institute — Detroit, Michigan, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.