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New treatment option for Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Official title TmPSMA-02 in mCRPC
ClinicalTrials.gov ID: NCT06046040
What this study is testing
What is TmPSMA-02 CAR T Cells?
TmPSMA-02 CAR T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castrate-resistant prostate cancer (mcrpc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Signed, written informed consent
- Adult participants ≥ 18 years of age
- Metastatic castrate-resistant prostate cancer (mCRPC)
- Castrate levels of testosterone (\<50 ng/dL) with/without the use of androgen-deprivation therapy
- Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor...
You likely can't join if
- Active hepatitis B or hepatitis C infection
- Any other active, uncontrolled infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
- Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a...
- Patients requiring chronic treatment systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with...
See the full eligibility criteria
- Signed, written informed consent
- Adult participants ≥ 18 years of age
- Metastatic castrate-resistant prostate cancer (mCRPC)
- Castrate levels of testosterone (\<50 ng/dL) with/without the use of androgen-deprivation therapy
- 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...
- Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:
- Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis
- ALT/AST ≤ 3 x ULN
- 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)
- Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
- 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...
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1000/μL
- Platelet count ≥ 75,000/μL
- ECOG Performance Status that is either 0 or 1.
- Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study.
- Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.
- Active hepatitis B or hepatitis C infection
- Any other active, uncontrolled infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
- 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...
- 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...
- Prior treatment with autologous T-cell therapy, with the exception of Sipuleucel-T.
- Prior allogeneic stem cell transplant.
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.