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CAR T-cell Therapy

P-PSMA-101 CAR-T Cells for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Poseida Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects ≥18 years of age

Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL) (mCRPC subjects only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 15 years

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with advanced prostate cancer (mCRPC) or salivary gland cancers (SGC). Participants should be relatively healthy, able to perform daily activities with ease or minor difficulty (ECOG status of 0-1), and have organs functioning within certain limits. Men must agree to use birth control during the study and for two years after.Check my eligibility

What is being tested?

The trial is testing P-PSMA-101 CAR-T cells, a type of personalized immune cell therapy designed to target cancer cells in patients with mCRPC and SGC. It's an open-label study where everyone gets the treatment, and doses will increase gradually to find out how much can be given safely.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells by mistake, flu-like symptoms, fatigue, fever, changes in blood pressure or heart rate, breathing difficulties, organ inflammation, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer can be measured by scans or, if only in bones, by a PSA test showing at least 1 ng/mL.

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I can carry out all my usual activities without help.

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My vital organs are functioning well.

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I have been diagnosed with metastatic castration-resistant prostate cancer or small cell prostate cancer.

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My prostate cancer has worsened despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the Safety of P-PSMA-101

Assess the efficacy of P-PSMA-101 (ORR)

Determine the maximum tolerated dose of P-PSMA-101

Trial Design

4Treatment groups

Experimental Treatment

Group I: P-PSMA-101 CAR-T cells (Single Dose - Part 1c)Experimental Treatment2 Interventions

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

Group II: P-PSMA-101 CAR-T cells (Single Dose - Part 1a)Experimental Treatment2 Interventions

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Group III: P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)Experimental Treatment2 Interventions

Cyclic administration of ascending dose cohorts, given via intravenous infusions of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

Group IV: P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)Experimental Treatment2 Interventions

Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Poseida Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

636 Total Patients Enrolled

Matthew Spear, M.D.Study DirectorSponsor Chief Medical Officer

1 Previous Clinical Trials

231 Total Patients Enrolled

Rajesh Belani, M.D.Study DirectorSponsor Executive Medical Director

4 Previous Clinical Trials

536 Total Patients Enrolled

Media Library

P-PSMA-101 CAR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04249947 — Phase 1

Prostate Cancer Research Study Groups: P-PSMA-101 CAR-T cells (Single Dose - Part 1a), P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b), P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d), P-PSMA-101 CAR-T cells (Single Dose - Part 1c)

Prostate Cancer Clinical Trial 2023: P-PSMA-101 CAR-T cells Highlights & Side Effects. Trial Name: NCT04249947 — Phase 1

P-PSMA-101 CAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249947 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

2020. "P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04249947.

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