Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

Summary

A Phase 1, open-label, single ascending dose (SAD) 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.

Official Title

Open-Label, Multicenter, Single Ascending Dose 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)

Details

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 containing a two arm cycle dosing regime. 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. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

Keywords

Multiple Myeloma CAR-T cells Neoplasms, Plasma Cell P-BCMA-101 CAR-T cells Rimiducid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California San Diego accepting new patients
    San Diego California 92093 United States
  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Poseida Therapeutics, Inc.
ID
NCT03288493
Phase
Phase 1/2
Study Type
Interventional
Last Updated