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

  • Interventional
  • Recruiting
  • NCT03288493
Eligibility Details Visit Clinicaltrials.gov

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)

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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

        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, 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

At a Glance

National Government IDNCT03288493

IRB#IRB19-0335

Lead SponsorPoseida Therapeutics, Inc.

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting