CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 40 target
Drug / intervention
TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3biological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Advanced cancers resistant to standard therapies
  • ✓Life expectancy greater than 12 weeks
  • ✓Adequate cardiac, pulmonary, hepatic, and renal function
  • ✓Available tumor tissue or malignant effusions for biopsy
Key exclusion· 6
  • ✕Prior gene therapy
  • ✕Chronic viral infections including HBV, HCV, or HIV
  • ✕Active bacterial, viral, or fungal infection
  • ✕Pregnancy or lactation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04842812
NCT04842812Phase 1RecruitingOn TrackUpdated 24mo ago
Long Recruiting
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Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Apr 13, 2021·Updated Jun 25, 2024

In Brief

A Phase 1 clinical trial evaluating TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3 for Liver Cancer and 7 related conditions. Currently recruiting, targeting 40 participants across 1 site.

Detailed Summary

Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Brain Tumor, Solid Tumor, Adult, PD1, CTLA4
CountriesChina
CollaboratorsGuangdong Zhaotai InVivo Biomedicine Co. Ltd.

Timeline

Phase 1Recruiting
202120222023202420252026202720282029203020312032203320342035
First PostedApr 13, 2021
Enrollment StartJan 1, 2021
Primary CompletionDec 31, 2029
Study CompletionJan 1, 2035
TodayJul 1, 2026
Enrollment to primary: 9 yearsPosted 5.2 years agoPrimary completion in 3.5 years

Interventions

TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3biological

TILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.