Summary

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

Description

Summary

This is a Phase 1, open-label, multi-center study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed and/or refractory MM. 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 and/or Refractory Multiple Myeloma (MM)

Details

The study will follow a 3 + 3 design of dose-escalating cohorts. 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. 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 and/or refractory MM, having received treatment with proteasome inhibitor and IMiD
  • 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, amyloidosis, significant autoimmune, CNS or other malignant disease
  • Has an active systemic infection
  • 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

Locations

  • University of California San Diego accepting new patients
    San Diego California 92121 United States
  • Colorado Blood Cancer Institute accepting new patients
    Denver Colorado 80218 United States

Details

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