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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:September 20, 2017
End Date:June 30, 2022
Contact:Michelle Resler
Email:mresler@poseida.com
Phone:1-858-779-3100

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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.

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
We found this trial at
6
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Houston, Texas 77030
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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San Diego, California 92093
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San Diego, CA
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