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LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer | Clinical Trials | Clareo Health

SUSPENDEDPHASE1

LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer

A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART Co-expressing LIGHT in Treating Patients With Castrate-Resistant Prostate Cancer (CRPC)

NCT04053062•Bioray Laboratories

View on ClinicalTrials.gov

Summary

This is a single center, single arm Phase I study to establish the safety and efficacy of intravenously administered lentivirally transduced LIGHT-PSMA-specific CAR modified autologous T cells (PSMA-CART cells) in patients with CRPC.

Detailed Description

This is a Phase I study evaluating the safety and efficacy of PSMA targeting autologous CAR T cells co-expressing LIGHT in a 3+3 dose escalation design. Cohort 1 subjects (N=3 or 6) will receive a tolal dose of 3x 10\^6/kg body weight (KgBW) LIGHT-PSMA-CART cells at split doses after a conditioning chemotherapeutic regimen(Cy+Flu). If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs, the study will advance to Cohort 2, with a total dose of 6 x 10\^6/ KgBW.

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Fully understand and voluntarily sign informed consent.
•Male, aged 18 to 75 years old.
•Expected survival \> 6 months.
•CRPC patients: Prostate cancer is still progressing after continuous androgen deprivation therapy. Including, castrate levels of serum testosterone (\<50ng/dl or \<1.7nmol/L); or prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, and PSA\>1 ug/L; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
•CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastasis).
•Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
•ECOG score \<2.
•Hgb \> 10 g/dl.
•PLT \> 100×109/L.
•ANC \> 1.5×109/L.

Exclusion Criteria

•Prior treatment with any immunotherapy, including CART therapy, tumor vaccine therapy, radium-223, checkpoint inhibitors.
•Prior treatment with any PSMA targeting therapy.
•Subjects with severe mental disorders.
•Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (LVEF \< 55%) was decreased by echocardiography or MUGA scan (within 8 weeks before PBMC collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
•Patients with ongoing or active infection.
•Aspartate aminotransferase or Alanine aminotransferase \>2.5\*ULN; CK\>1.5\*ULN; CK-MB\>1.5\*ULN; TnT\>1.5\*ULN.
•Total bilirubin \>1.5\*ULN.
•Partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*ULN without anticoagulant treatment.
•History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
•Intolerant or allergic to cyclophosphamide or fludarabine.
+1 more criteria

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 16, 2020

Primary Completion Date

May 15, 2022

Completion Date

October 15, 2024

Last Updated

January 5, 2024

Enrollment

ESTIMATED participants

Conditions

Castrate-Resistant Prostate Cancer

Interventions

LIGHT-PSMA-CART cells

BIOLOGICAL

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

NCT02266745

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TERMINATEDPHASE2

OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

NCT01681433

Prostate CancerMetastatic Castrate-Resistant Prostate Cancer+1 more

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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: January 5, 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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LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer