Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Phase 1/2, Open-label, Multi-Center Study of Dually Armored Chimeric Antigen Receptor (CAR) T-cells (TmPSMA-02) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
An open-label, multi-center, Phase 1/2 study to determine the safety, tolerability, and feasibility of dosing adult patients with mCRPC with genetically modified autologous T-cells (TmPSMA-02) engineered to express a CAR capable of recognizing the tumor antigen prostate-specific membrane antigen (PSMA) and activating the T-cell.
This is a Phase 1/2 single-arm study designed to identify the dose and regimen of TmPSMA-02 that can be safely administered intravenously following the lymphodepletion (LD) regimen to patients with mCRPC. The Phase 1 dose escalation portion of the study will employ a Bayesian Optimal Interval (BOIN) Design to define the Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D). Dose-limiting toxicities (DLTs) will be assessed from the start of LD regimen through 28-days post infusion of TmPSMA-02. The Phase 2 portion will employ a Simon's 2-stage design and include a single-arm of adult patients with mCRPC treated with the TmPSMA-02 at the RP2D. It is anticipated that up to 30 patients will enroll in the Phase 1 portion of the study and up to 84 patients will enroll in the Phase 2 portion of the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04986423 -
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Active, not recruiting |
NCT05521412 -
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
|
Phase 1/Phase 2 | |
| Terminated |
NCT04556617 -
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
| Completed |
NCT02125357 -
Sequencing Abiraterone and Enzalutamide in mCRPC
|
Phase 2 | |
| Recruiting |
NCT06052306 -
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
| Recruiting |
NCT05917470 -
A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05519449 -
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
|
Phase 1 | |
| Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
| Recruiting |
NCT05383079 -
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04060394 -
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
|
Phase 1/Phase 2 | |
| Completed |
NCT01942837 -
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05458544 -
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04879589 -
Phase 1 Study of ATRS-2002 in Healthy Male Adults
|
Phase 1 | |
| Recruiting |
NCT03230734 -
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05116579 -
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
|
||
| Active, not recruiting |
NCT03732820 -
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT05005728 -
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05762536 -
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
|
Phase 2 | |
| Recruiting |
NCT06067841 -
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer
|
Phase 1 |