Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration 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.
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. 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, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
SparkCures ID | 913 |
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Trial Phase | Phase 1 |
Enrollment | 220 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Exclusion Criteria:
The following is a listing of trial locations that are open and accepting patients.
SparkCures Verified Accurate, up-to-date information. Learn more
La Jolla, CA
Sacramento, CA
Kansas City, KS
Philadelphia, PA
Nashville, TN
Seattle, WA
The following is a listing of trial locations that are not currently open and accepting patients.
SparkCures Verified Accurate, up-to-date information. Learn more
La Jolla, CA
Sacramento, CA
Kansas City, KS
Philadelphia, PA
Nashville, TN
Seattle, WA
May 13, 2019
According to results presented at the 2018 ASH Annual Meeting, 23 patients received treatment with P-BCMA-101 in 1 of 5 dose cohorts and no dose-limiting toxicities were observed at any dose.
All 3 patients who received P-BCMA at a mean dose of 857 x 106 achieved a response, with 2 achieving a very good partial response. The third patient achieved a partial response and minimal residual disease negativity. Seven patients received a mean dose of 456 x 106 and the objective response rate was 43% in these patients. In the 7 patients who received a mean dose of 152 x 106, the objective response rate was 71%. A minor response or better was seen in 13 of 19 evaluable patients by IMWG criteria.
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