Status:
ACTIVE_NOT_RECRUITING
PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies side effects and best dose of PSCA-chimeric antigen receptor (CAR) T cells in treating patients with prostate stem cell antigen positive (PSCA+) castration resistant prostat...
Detailed Description
PRIMARY OBJECTIVES: I. Define the safety and tolerability of autologous anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T lymphocytes (PSCA-CAR T cells) in patients with PSCA+ metastatic castration resi...
Eligibility Criteria
Inclusion
- All participants must have the ability to understand and the willingness to sign a written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 or KPS ≥70%.
- Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist therapy)
- Documented PSCA+ tumor expression as evaluated by City of Hope (COH) Pathology Care
- Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide)
- Rising PSA documented on 2 occasions at least 7 days apart, with absolute increase \> 2 ng/dL despite testosterone \< 50 OR
- Radiographic evidence of new metastatic foci on computed tomography (CT) or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)
- Prior chemotherapy with cabazitaxel and/or docetaxel is allowed but not required. If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis
- Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was \> 14 days prior to leukapheresis
- No known contraindications to leukapheresis, steroids or tocilizumab
- Total serum bilirubin =\< 2.0 mg/dL (to be performed within 42 days of signing the main study consent)
- Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN
- Aspartate aminotransferase (AST) \< 5 x ULN (to be performed within 42 days of signing the main study consent)
- Alanine aminotransferase (ALT) \< 5 x ULN (to be performed within 42 days of signing the main study consent)
- Creatinine clearance of \>= 50 mL/min per the Cockcroft-Gault formula (to be performed within 42 days of signing the main study consent)
- Cardiac function (12 lead-electrocardiography \[ECG\]) without acute abnormalities requiring investigation or intervention (to be performed within 42 days of signing the main study consent)
- Left ventricular ejection fraction \> 40% (to be performed within 42 days of signing the main study consent)
- Participants of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment
Exclusion
- Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the main consent
- Participants with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder
- History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
- History of stroke or intracranial hemorrhage within 6 months prior to signing the main consent
- History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Human immunodeficiency virus (HIV) infection
- Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03873805
Start Date
August 20 2019
End Date
April 13 2026
Last Update
June 26 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010