Trials / Terminated
TerminatedNCT04249947
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Poseida Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC and SGC.
Detailed 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.
Conditions
- Prostatic Neoplasms, Castration-Resistant
- Neoplasms by Histologic Type
- Neoplasms, Prostate
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
- Neoplasms
- Prostatic Neoplasms
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Prostatic Disease
- Salivary Gland Cancer
- Salivary Gland Tumor
- Adenoid Cystic Carcinoma
- Salivary Duct Carcinoma
- Mucoepidermoid Carcinoma
- Acinic Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | P-PSMA-101 CAR-T cells | P-PSMA-101 is an autologous chimeric antigen receptor (CAR) T-cell therapy designed to target prostate cancer cells expressing the cell surface antigen prostate-specific membrane antigen (PSMA). |
| DRUG | Rimiducid | Rimiducid (safety switch activator) may be administered as indicated |
Timeline
- Start date
- 2020-02-28
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
- First posted
- 2020-01-31
- Last updated
- 2025-02-17
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04249947. Inclusion in this directory is not an endorsement.