P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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- STATUS
- Recruiting
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- End date
- Sep 28, 2036
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- participants needed
- 40
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- sponsor
- Poseida Therapeutics, Inc.
Summary
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC.
Description
This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D.
Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.
Details
| Condition | Malignant neoplasm of prostate, Cancer, Prostatic disorder, Genitourinary Neoplasms, Genital Neoplasms, Male, Neoplasms by Histologic Type, Neoplasms by Site, Prostatic Neoplasms, Castration-Resistant, Metastatic Castration-resistant Prostate Cancer |
|---|---|
| Age | 18-100 years |
| Treatment | P-PSMA-101 CAR-T cells, Rimiducid |
| Clinical Study Identifier | NCT04249947 |
| Sponsor | Poseida Therapeutics, Inc. |
| Last Modified on | 19 February 2024 |
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