TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

NCT06088472 | Recruiting Phase 1

• 1 other identifier: GRIT-CO-FA-012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events per CTCAE 5.0

  To characterize the safety profile of autologous TIL injection (GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0

  From TIL infusion to the 24th week

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 24 months post infusion

• Disease control rate (DCR)

  Up to 24 months post infusion

• Progression-free survival (PFS)

  Up to 24 months post infusion

• Duration of Response (DoR)

  Up to 24 months post infusion

• Overall survival (OS)

  From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first)

Study Arms (1)

TIL injection treatment group

EXPERIMENTAL

Biological: TIL injection

Interventions

TIL injection BIOLOGICAL

Autologous tumor infiltrating lymphocyte injection

TIL injection treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
• Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
• At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

You may not qualify if:

• \. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
• The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone) within 14 days before lymphocyte depletion chemotherapy;
• \. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
• \. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
• \. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);

Sponsors & Collaborators

• Grit Biotechnology: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Interventions

Toll-Like Receptor 1

Intervention Hierarchy (Ancestors)

Toll-Like Receptors; Receptors, Pattern Recognition; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Zhengxiang Han, PHD

CONTACT

+86 18052268612; cnhzxyq@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: April 21, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)