Clinical trial · Interventional
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)
NCT04053062CI-TRIAL-00072782suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to efficacy evaluation
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Castrate-Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LIGHT-PSMA-CART cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LIGHT-PSMA-CART
- description
- Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -6 to -4. Patients receive LIGH-PSMA-CART IV at split doses from day 0 on.
- interventionNames
- Biological: LIGHT-PSMA-CART cells
Primary outcomes (1)
- measure
- Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- timeFrame
- 28 days
- description
- All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: Subjects who meet any of the following exclusion criteria will be excluded * 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. * Subjects not appropriate to participate in this clinical study judged by investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.