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.

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.

Keywords

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

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
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 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
August 6, 2018