What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including docetaxel, ADT, enzalutamide, and radioligand therapies like lutetium Lu 177 vipivotide tetraxetan, have various side effects. Docetaxel and ADT can cause fatigue, nausea, and myelosuppression. Enzalutamide is associated with fatigue, anorexia, and nausea, with some patients experiencing a PSA flare. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan can lead to myelosuppression, nephrotoxicity, and salivary gland toxicity, including dry mouth. These treatments are generally well-tolerated but can have significant adverse effects that need to be managed.

What prior FDA approvals exist?

The FDA has approved several advanced treatments for prostate cancer, particularly for metastatic castration-resistant prostate cancer (mCRPC). One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy targeting PSMA, which has shown significant improvements in progression-free survival and overall survival. Additionally, immune checkpoint inhibitors like pembrolizumab have been approved for mCRPC patients with specific genetic markers such as dMMR or high TMB. These treatments represent significant advancements in targeting specific molecular features of prostate cancer, similar to the investigational P-PSMA-101 CAR-T cells targeting PSMA.

What other types of research exist?

Promising novel alternatives to P-PSMA-101 autologous CAR-T cells for prostate cancer patients include: <ol> <li>Anti-BCMA CAR-T cells (e.g., idecabtagene vicleucel, ciltacabtagene autoleucel)</li> <li></li> </ol> Bispecific T cell engagers (BiTEs) such as teclistamab, AMG 701, and CC93269 3. Anti-PD-1 therapy, with or without anti-CTLA-4 therapy 4. Dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy 5. Lutetium-177 [177Lu]Lu-PSMA-617, a radiolabelled small molecule targeting PSMA

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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

No Placebo-Only Group

Summary

This trial tests a treatment where a patient's immune cells are modified to better fight advanced prostate and salivary gland cancers. The modified cells are reintroduced into the body to target and destroy cancer cells.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the Safety of P-PSMA-101

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

Determine the maximum tolerated dose of P-PSMA-101

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CAR-T cell therapy, such as P-PSMA-101, involves engineering a patient's T cells to express receptors that specifically target PSMA on prostate cancer cells, enhancing the immune system's ability to recognize and destroy these cells. This is significant for prostate cancer patients as it offers a targeted approach to treatment, potentially improving efficacy and reducing side effects compared to traditional therapies. Other common treatments include androgen deprivation therapy (ADT), which lowers androgen levels to inhibit cancer growth, and immunotherapies like sipuleucel-T, which boost the immune system's response against cancer cells. Understanding these mechanisms helps patients make informed decisions about their treatment options.

Differential CARM1 expression in prostate and colorectal cancers.