The Use of P-PSMA-101 CAR-T Cells to Threat Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients

Patient Summary

This clinical trial is for patients with metastatic castration-resistant prostate cancer (mCRPC) that has worsened despite having received hormonal and chemotherapeutic treatments.

This study investigates the safety and effects (good or bad) of using P-PSMA-101-001 to treat metastatic castration-resistant prostate cancer (mCRPC), which has spread to other parts of the body and is resistant to standard hormonal therapies.

P-PSMA-101 is a new immunotherapy called a CAR-T, which is made from the patient's white blood cells. P-PSMA-101 interacts with prostate surface membrane antigen (PSMA), protein commonly located on the surface of prostate cancer cells.

What is the goal of the study?

The purpose of this study is to determine if P-PSMA-101 is safe and will help treat patients with metastatic prostate cancer that has worsened despite having received treatment hormonal therapy and chemotherapy.

When the patient's T cells recognize PSMA, it kills the cell with PSMA on the cell surface.

This study investigates the safety and effects (good or bad) of using P-PSMA-101-001 to treat metastatic castration-resistant prostate cancer (mCRPC), which has spread to other parts of the body and is resistant to standard hormonal therapies.

What is the purpose?

The purpose of this study is to determine if P-PSMA-101 is safe and will help treat patients with metastatic prostate cancer that has worsened despite having received treatment hormonal therapy and chemotherapy.

The trial objective is to determine if P-PSMA-101 is safe and helps treat patients with metastatic prostate cancer that has worsened despite receiving treatment hormonal and chemotherapeutic treatments.

The information obtained from this study will assist in the design of future P-PSMA-101-001 studies.

Who can participate?

This phase 1 clinical trial plans to enroll 40 participants, beginning January 31, 2020. Selected patients will receive P-PSMA-101 by intravenous infusion. In addition, the patient may be eligible to receive one or more infusions during the study.

What happens?

Following consent and enrollment:

• The patient's white blood cells will be removed and sent to a laboratory to produce P-PSMA-101 CAR-T cells.
• The modified immune cells will then be returned to the investigational site and given after undergoing a WBC depletion procedure.
• To increase the therapeutic effectiveness of P-PSMA-101, patient my receive Rimiducid.

Possible patient benefits

• The use of this therapy could include slowing down or stopping the progression of prostate cancer and potentially prolonging life.
• Patients will be under close medical supervision for safety during the study period.

Possible patient risks:

• The use of P-PSMA-101 will provide no benefit for preventing disease progression in these patients.
• The use of P-PSMA-101 may also cause side effects.

Contact and Clinical Trial Sites

• Contact and Trial site information are be found here

• ClinicalTrials.gov Identifier: NCT04249947
• For additional information, go to Poseida Therapeutics
• Use the "clinical trials glossary" and "dictionary" for words, phrases, and treatments that you may not understand.
• Register your interest or comments about this trial with PHEN

PHEN Contact: 617-481-4020

Please Note: This information is provided for educational and awareness purposes. The patient and his doctor will decide on clinical trial participation.

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