RECRUITING

TmPSMA-02 in mCRPC

Conditions

Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

Official Title

Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T Cells (TmPSMA-02) in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Quick Facts

Study Start:2024-01-31

Study Completion:2042-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06046040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed, written informed consent 2. Adult participants ≥ 18 years of age 3. Metastatic castrate-resistant prostate cancer (mCRPC) 4. Castrate levels of testosterone (\<50 ng/dL) with/without the use of androgen-deprivation therapy 5. Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc). 6. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as: 1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis 2. ALT/AST ≤ 3 x ULN 3. Serum total bilirubin ≤ 1.5 mg/dL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg/dL) 4. Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO 5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air 7. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as: 1. Hemoglobin ≥ 8 g/dL 2. Absolute neutrophil count ≥ 1000/μL 3. Platelet count ≥ 75,000/μL 8. ECOG Performance Status that is either 0 or 1. 9. Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study. 10. Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.	1. Active hepatitis B or hepatitis C infection 2. Any other active, uncontrolled infection 3. Class III/IV cardiovascular disability according to the New York Heart Association Classification. 4. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study. 5. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\]. 6. Patients requiring chronic treatment systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg/day or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.6. 7. Prior treatment with autologous T-cell therapy, with the exception of Sipuleucel-T. 8. Prior allogeneic stem cell transplant. 9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded. 10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).

Inclusion Criteria

Exclusion Criteria

1. Signed, written informed consent
2. Adult participants ≥ 18 years of age
3. Metastatic castrate-resistant prostate cancer (mCRPC)
4. Castrate levels of testosterone (\<50 ng/dL) with/without the use of androgen-deprivation therapy
5. Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).
6. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:
1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis
2. ALT/AST ≤ 3 x ULN
3. Serum total bilirubin ≤ 1.5 mg/dL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg/dL)
4. Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO
5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
7. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:
1. Hemoglobin ≥ 8 g/dL
2. Absolute neutrophil count ≥ 1000/μL
3. Platelet count ≥ 75,000/μL
8. ECOG Performance Status that is either 0 or 1.
9. Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study.
10. Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.

1. Active hepatitis B or hepatitis C infection
2. Any other active, uncontrolled infection
3. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
4. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
5. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\].
6. Patients requiring chronic treatment systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg/day or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.6.
7. Prior treatment with autologous T-cell therapy, with the exception of Sipuleucel-T.
8. Prior allogeneic stem cell transplant.
9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).

Contacts and Locations

Study Contact

Abramson Cancer Center Clinical Trials Service

CONTACT

215-349-8245

PMCancerResearch@pennmedicine.upenn.edu

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31

Study Completion Date2042-01-31

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2042-01-31

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Castrate-Resistant Prostate Cancer (mCRPC)