Hi-TCR-T Treatment for Solid Tumors

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Registration Number	Trial Location	Study Design	Intervention
ChiCTR2400092563	Shanghai, China	Single arm	Hi-TCR-T cell injection targeting Nectin4/NKG2DL/FAP

Ages 18-70

All Genders

Advanced solid tumors are cancers that have progressed to late stages, often with metastasis or recurrence after standard treatments such as surgery, chemotherapy, or radiotherapy. Common tumor types include liver cancer, lung cancer, gastric cancer, pancreatic cancer, colorectal cancer, and breast cancer. These tumors are typically difficult to treat, and patients may have limited therapeutic options.

This clinical trial is recruiting patients with advanced solid tumors of pan cancer species who have failed standard therapy, or currently no standard therapy is available.

Treatment Protocol

The study employs an interventional research approach and is in the exploratory/preliminary phase, with a single-arm design. This means all enrolled patients will receive a uniform intervention-a super-powerful Hi-TCR-T cell injection.

Intervention Overview

Participating patients will receive Hi-TCR-T cells targeting Nectin4, NKG2DL, TROP2, B7-H3, and FAP. These modified cells possess the following characteristics:

Enhanced attack power: Secreting IL-7 and super IL-15, which aids in self-proliferation and continuous tumor recognition;
Guiding immune cells: Secreting CCL21, attracting more immune cells to the tumor region;
Removing suppression: Blocking tumor immunosuppressive signals through anti-TGFβ1 scFv and anti-PD-1 scFv, enabling immune cells to kill tumors more effectively.

More about Hi-TCR-T Cell Therapy

Treatment Process

Screening and Assessment: Comprehensive screening and baseline assessment, including histological or clinical confirmation of HCC, laboratory tests, and imaging studies.
Blood Collection: Extracting T cells from the patient for modification.
Cell Modification and Culture: The laboratory modifies T cells into super-efficient Hi-TCR-T cells and expands them to a sufficient number in a safe and controlled environment.
Pretreatment: Short-term low-dose chemotherapy may be administered depending on the patient's condition to provide a better growth environment for T cells.
Cell Reinfusion: The modified Hi-TCR-T cells are reinfused into the body via intravenous injection.
Follow-up Monitoring: Regular imaging and hematological examinations are performed during hospitalization and after discharge to monitor efficacy and safety.

Patient Recruitment Criteria

Inclusion Criteria

Age 18-70 years old (including 70 yrs), male or female.
Advanced recurrent or metastatic solid tumors confirmed by histological or cytological evaluation and that have failed standard therapy, or currently no standard therapy is available.
The presence of at least one measurable lesion according to RECIST 1.1 criteria.
By the immunohistochemical detection, tumor cells Nectin4 / NKG2DL/TROP2 / B7H3 / FAP express some positive (at least two targets positive).
ECOG physical condition score is 0-2 points.
The subjects had no contraindications for peripheral blood monopexy.
Expected survival time ≥3 months.
Major organ function is normal, that is, meet the following criteria:

Medical Testing	Parameter	Threshold / Criteria
Hematology	Hemoglobin	≥90 g/L
	Absolute neutrophil count (ANC)	≥1.5×10⁹ /L
	Platelet count	≥100×10⁹ /L
Biochemistry	Serum albumin	≥ 28
	Total bilirubin	≤ 2 × ULN
	AST (Aspartate aminotransferase)	≤ 3 × ULN
	ALT (Alanine aminotransferase)	≤ 3 × ULN
	Alkaline phosphatase (ALP)	≤ 3 × ULN
	Creatinine	≤ 1.5 × ULN
Coagulation	International standardized ratio (INR) or prothrombin time (PT)	≤1.5×ULN
Coagulation	Activated partial thromboplastin time (APTT)	≤1.5×ULN
Cardiac	Left ventricular ejection fraction (LVEF)	≥50% (No serious arrhythmias)
Pulmonary / Oxygenation	SpO₂ (room air)	≥92% (No serious lung or kidney disease. No active lung infection.)

Exclusion Criteria

Uncontrolled active infection or expected to receive systemic anti-infection or immunosuppressive therapy during the study.
Received chemotherapy, radiotherapy or surgery within 4 weeks prior to chemotherapy preconditioning.
Received targeted drug therapy within 2 weeks before chemotherapy preconditioning.
Any toxicity caused by previous antitumor therapy before chemotherapy preconditioning has not returned to grade 1 or below (CTCAE version 5.0).
Previous history of organ/stem cell transplantation, or expected need for organ/stem cell transplantation during the study.
History of primary malignancies of other systems within the past 3 years (except cervical carcinoma in situ).
Active central nervous system disease or known concomitant brain metastases with significant neurological/psychiatric symptoms as assessed by MMSE.
Known allergy to 2 or more non-similar foods/drugs, or known allergy to chemotherapy preconditioning drugs (including cyclophosphamide, fludarabine, interleukin).
HIV infection.
Pregnant or lactating women.
The investigator believes that the subjects have other conditions that are not suitable for participation in this study.

Treatment Cost

This clinical study is a chargeable treatment program. Participating patients are responsible for the costs of the study intervention and related examinations. The costs mainly include:

Cost of Hi-TCR-T cell preparation and injection treatment;
Cost of necessary blood, imaging, and other laboratory tests during treatment;
Fees for basic medical services during hospitalization (such as nursing care, medication, etc.).

For detailed fees, travel/visa support, accommodation and logistics, please contact us for a personalized consultation.

If you interested in this clinical study, please contact us at any time. We will provide you with a detailed introduction to the research and arrange an online consultation between you and the physician investigator.

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