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Recruiting NCT04842812

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

Phase I Interventional Liver Cancer Lung Cancer Breast Cancer Colo-rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3.
Who it may be relevant to
Registry conditions: Liver Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors

Overview

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.

Detailed description

1. Choose appropriate patients with advanced lung or other cancers, with written consent for this study; 2. Perform biopsy or collect cancerous effusion in thorax or abdomen to obtain TILs by standard protocol; 3. Grow TILs and engineered the tumor-effective TILs with CRISPRA-CAS9 technique to knockdown PD1 and electronic-transfection strategy to express scFvs that target PD1 and CTLA4; amplify the engineered T cells as needed, test the quality and killing activity of the TILs and then transfuse them back the patients via systemic or local injections via standard protocol, and follow up closely to collect related parameters as needed; 4. To enhance the killing capability, tumor-noneffective TILs have also been genetically engineered to express various CARs targeting HER2/Mesothelin/Lewis-Y/PSCA/MUC1/ GPC3/AXL/EGFR/Claudin18.2/B7-H3/ROR1/GD2/AXL/Claudin6-DAP10 with knockdown of PD1/HPK1 as appropriate; 5. Evaluate the clinical results as needed.

Interventions

  • Biological TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3
    TILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.

Primary outcome measures

  • Safety of TILs/CAR-TILs treatment in advanced solid cancers [Time frame: up to 36 months]
Secondary outcome measures (1)
  • Primary clinical efficacy of the TILs/CAR-TILs treatment in advanced solid cancers [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

  • Patients with advanced cancers that failed to current available therapies;
  • Life expectancy >12 weeks;
  • Adequate heart, lung, liver, kidney functions;
  • Available for tumor biopsy or cancerous effusions;
  • Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Exclusion criteria

  • Had accepted gene therapy before;
  • Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity;
  • Active infectious disease related to bacteria, virus, fungi, et al;
  • Other severe diseases that the investigators consider not appropriate;
  • Pregnant or lactating women;
  • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
  • Other conditions that the investigators consider not appropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT04842812 · ZZTIL-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗