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CAR T-cell Therapy
A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
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
No Placebo-Only Group
Summary
This trial tests a new treatment using a patient's own modified immune cells to target advanced prostate cancer that resists standard treatments. The modified cells are designed to find and destroy cancer cells by recognizing a unique marker on them. A similar treatment has shown improved survival in patients with advanced prostate cancer.
Eligible Conditions
- 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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TmPSMA-02Experimental Treatment1 Intervention
Find a Location
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
137 Total Patients Enrolled