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CAR T-cell Therapy

TmPSMA-02 for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Tceleron Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trialtests a gene-modified T-cell therapy to treat prostate cancer. It will measure safety, effectiveness, and feasibility.

Eligible Conditions

Metastatic Castration Resistant Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Phase 1: To evaluate the safety of TmPSMA-02 in adult patients with mCRPC

Phase 1: To identify the recommended Phase 2 dose of TmPSMA-02 administered in combination with LD chemotherapy

Phase 2: To evaluate the objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

Secondary outcome measures

Phase 1: To assess the clinical and manufacturing feasibility of TmPSMA-02

Phase 1: To evaluate the preliminary antitumor activity of TmPSMA-02 according to RECIST v1.1 and the PCWG3 criteria

Phase 2: Describe pharmacokinetic factors of TmPSMA-02 in peripheral blood

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TmPSMA-02Experimental Treatment1 Intervention

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Who is running the clinical trial?

Tceleron Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

34 Total Patients Enrolled

Tmunity TherapeuticsLead Sponsor

6 Previous Clinical Trials

148 Total Patients Enrolled

Frequently Asked Questions

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

How many patients are being enrolled in this clinical trial?

"That is accurate. The information available on clinicaltrials.gov points to this fact that this trial is currently looking for participants. This trial was originally posted on September 6th, 2020 and was edited October 17th, 2020. There is a goal to recruit 114 people from 1 location."

Answered by AI

What are the main goals that we hope to achieve with this clinical trial?

"The primary objective of this clinical trial, as measured over a period of up to 5 years, is to evaluate the objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 in patients receiving TmPSMA-02 cells. Additionally, the trial will be assessing secondary outcomes including duration of response (DOR), prostate specific antigen (PSA) percent change from baseline at 12 weeks and maximal change calculated at any time point, progression free survival (PFS), radiographic progression free survival (rPFS), and overall survival (OS). Finally, the trial"

Answered by AI

If I am interested, can I join this trial now?

"The trial, which was initially reported on September 6th, 2020 is still recruiting patients according to the most recent update on October 17th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

2022. "A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05489991.