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Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC

The Safety and Efficacy Evaluation of Enhanced Autologous PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer

NCT06228404•Shanghai Changzheng Hospital

View on ClinicalTrials.gov

Summary

Detailed Description

This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C). Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Fully understood and voluntarily signed informed consent for this study;
•2. male, aged 18-75 years;
•3. expected survival of more than 6 months;
•4. metastatic castration-resistant prostate adenocarcinoma (CRPC) patients.
•5. Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression);
•6. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment;
•7. ECOG score \< 2 ;
•8. virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening method unknown, confirmed by nucleic acid method); hematological parameters met the following criteria: a. hemoglobin \> 100 g/L; b. platelet count \> 100 × 109/L; c. neutrophils \> 1.5 × 109/L.

Exclusion Criteria

•1. have received any previous treatment with CAR-T therapy ;
•2. have received any previous treatment that targets PSMA;
•3. tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
•4. severe mental disorders;
•5. suffered from previous malignancies, except for the following: a. basal cell carcinoma or squamous cell carcinoma after standardized treatment; b. having a primary malignancy, but completely resected, with a complete remission time of ≥ 5 years.
•6. Subjects with severe cardiovascular disease; a.New York Heart Association (NYHA) stage III or IV congestive heart failure; b.Myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); c.Clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; d.History of severe non-ischemic cardiomyopathy; e.Decreased left ventricular ejection fraction (LVEF \< 55%) as assessed by echocardiogram or multigated acquisition (MUGA) scan, abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis;
•7. active infectious disease or any major infectious event requiring high grade antibiotics;
•8. organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase \> 2.5ULN; CK \> ULN; CK-MB \> ULN; TnT \> 1.5ULN; b. total bilirubin \> 1.5ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio \> 1.5ULN in the absence of anticoagulant therapy;
•9. participation in other clinical studies in the past three months or previous treatment with any gene therapy product;
•10. intolerance or hypersensitivity to cyclophosphamide and fludarabine chemotherapy;
+1 more criteria

Locations (1)

Changzheng hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 3, 2024

Primary Completion Date

May 1, 2025

Completion Date

December 1, 2025

Last Updated

April 18, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate CancerCastration-resistant Prostate Cancer

Interventions

Enhanced autologous PSMA-CAR T

DRUG

Contacts

Shancheng Ren, MD/PhD

CONTACT

139 1779 3885 renshancheng@gmail.com

Weidong Xu

CONTACT

139 1687 9385 ayxwd@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer