Clinical trial · Interventional
CART-PSMA Cells for Advanced Prostate Cancer
Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer
NCT05656573CI-TRIAL-00082599recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-PSMA cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- autologous CART-PSMA cells
- description
- Cohort 1： CART-PSMA cells 1-3x10\^7/M\^2(body surface area) on Day 0; Cohort 2： CART-PSMA cells 1-3x10\^8/M\^2(body surface area) on Day 0; Cohort 3： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10\^7/M\^2(body surface area) on Day 0. Cohort 4： Lymphodepletion chemotherapy with fludarabine (30 mg/m2 body surface area) plus cyclophosphamide (300 mg/m2 body surface area) for 3 consecutive days during D-7 to D-3, followed by the infusion of CART-PSMA cells at 1-3x10\^8/M\^2(body surface area) on Day 0.
- interventionNames
- Drug: CART-PSMA cells
Primary outcomes (1)
- measure
- Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.
- timeFrame
- Up to 15 years
- description
- Assessing the type, frequency, severity, and duration of adverse events as a result of CART-PSMA cell infusion via physical, laboratory and imaging examination.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. All participants must have the ability to understand and the willingness to sign a written informed consent. 2. Histologic confirmation of prostate cancer. 3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. 5. Under general air conditions, blood oxygen saturation \>90%. 6. Adequate liver function, specifically alanine aminotransferase (ALT) \< 3 times of upper limit of normal (ULN), aspartate transferase (AST)\< 3 times of ULN, serum bilirubin and alkaline phosphatase \< 2 times of ULN. 7. Adequate renal function, specifically serum creatinine \< 2.0 mg/dl. 8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%. 9. Hemoglobin concentration ≥80g/L. 10. The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy. Exclusion Criteria: 1. Patients with other malignant tumors or major diseases. 2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy. 3. Patients with uncontrolled active infection. 4. Patients with active hepatitis B or hepatitis C infection. 5. Patients with human immunodeficiency virus (HIV) infection. 6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy). 7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease. 8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases. 9. Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy. 10. Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.
References
Publications (0)
Data not yet available
No reference posted for this study.