P-PSMA-101 CAR-T cells for Metastatic Castration Resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NYMetastatic Castration Resistant Prostate Cancer+16 MoreP-PSMA-101 CAR-T cells - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for men with metastatic prostate cancer that has not responded to other treatments. The treatment involves taking the patient's own immune cells, engineering them to better target the cancer, and infusing them back into the patient.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Prostate Disease
  • Prostate Cancer
  • Tumors
  • Salivary Gland Cancer
  • Salivary Duct Cancer
  • Urogenital Neoplasms
  • Male Genital Neoplasms
  • Acinic Cell Carcinoma
  • Adenoid Cystic Carcinoma
  • Castration-resistant Prostate Cancer
  • Mucoepidermoid Carcinoma
  • Cancer
  • Salivary Gland Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Baseline through 15 years

Baseline through 15 years
Assess the Safety of P-PSMA-101
Assess the efficacy of P-PSMA-101 (ORR)
Baseline through Day 28
Determine the maximum tolerated dose of P-PSMA-101

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

P-PSMA-101 CAR-T cells (Single Dose - Part 1a)
1 of 4
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)
1 of 4
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)
1 of 4
P-PSMA-101 CAR-T cells (Single Dose - Part 1c)
1 of 4

Experimental Treatment

60 Total Participants · 4 Treatment Groups

Primary Treatment: P-PSMA-101 CAR-T cells · No Placebo Group · Phase 1

P-PSMA-101 CAR-T cells (Single Dose - Part 1a)Experimental Group · 2 Interventions: P-PSMA-101 CAR-T cells, Rimiducid · Intervention Types: Biological, Drug
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)Experimental Group · 2 Interventions: P-PSMA-101 CAR-T cells, Rimiducid · Intervention Types: Biological, Drug
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)Experimental Group · 2 Interventions: P-PSMA-101 CAR-T cells, Rimiducid · Intervention Types: Biological, Drug
P-PSMA-101 CAR-T cells (Single Dose - Part 1c)Experimental Group · 2 Interventions: P-PSMA-101 CAR-T cells, Rimiducid · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimiducid
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through 15 years

Who is running the clinical trial?

Poseida Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
345 Total Patients Enrolled
Matthew Spear, M.D.Study DirectorSponsor Chief Medical Officer
1 Previous Clinical Trials
40 Total Patients Enrolled
Rajesh Belani, M.D.Study DirectorSponsor Executive Medical Director
4 Previous Clinical Trials
345 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must employ birth control measures from initial assessment and for a period of two years after the last dose of P-PSMA-101.
You must have achieved progression according to PCWG3 and/or RECIST 1.1 criteria (applicable only for metastatic castrate-resistant prostate cancer patients).
Your vital organs must be functioning within the accepted range.
You have an ECOG performance status of 0 to 1.
You are at least 18 years old.
The disease must be quantifiable according to RECIST 1.1 standards or involve bone metastases with a measurable PSA level of at least 1 ng/mL (applicable only to mCRPC subjects).
You have been diagnosed with metastatic castration-resistant prostate cancer or symptomatic, genetically confirmed colorectal cancer.

Frequently Asked Questions

How extensive is the geographical reach of this trial?

"The Dana-Farber Cancer Institute in Boston, City of Hope Comprehensive Cancer Center in Duarte and University of California San Francisco in San Francisco are a few clinical trial sites participating. Additionally, there are 10 other locations running the study." - Anonymous Online Contributor

Unverified Answer

Is the research team seeking out participants for this trial?

"This clinical trial has ceased recruitment of new patients; the original posting was made on February 28th 2020, and the last update was November 15th 2022. However, there are currently 5896 ongoing studies regarding prostatic diseases as well as 16 distinct trials searching for participants to evaluate P-PSMA-101 CAR-T cells treatments." - Anonymous Online Contributor

Unverified Answer

Has the effectiveness of P-PSMA-101 CAR-T cells been explored in prior research studies?

"As of now, there are 16 clinical investigations underway surrounding P-PSMA-101 CAR-T cells with none in their terminal phase. Most experiments relating to this subject matter are taking place in Nashville, Tennessee while 94 other sites worldwide have begun trials focusing on the same topic." - Anonymous Online Contributor

Unverified Answer

Has the FDA granted approval for P-PSMA-101 CAR-T cell treatments?

"With limited clinical data indicating efficacy and safety, the P-PSMA-101 CAR-T cell scored a 1 on our team's rating system." - Anonymous Online Contributor

Unverified Answer

How many participants are involved with this experiment?

"Unfortunately, the recruitment period for this clinical trial has closed. It was first posted on February 28th 2020 and last modified on November 15th 2022. However, there are currently 5896 studies recruiting participants with prostatic diseases as well as 16 trials looking for patients to receive P-PSMA-101 CAR-T cells." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.