TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

A Single-arm Phase I Clinical Study of TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumors, Adult
• Intervention / Treatment: Biological: TIL injection

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
• 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
• 3.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;

Exclusion Criteria:

• 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
• 2.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;
• 3. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• 4.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;
• 5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
• 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 7.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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIL injection treatment group	Biological: TIL injection; Autologous tumor infiltrating lymphocyte injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.	Up to 24 months post infusion
Disease control rate (DCR)	To evaluate the percentage of participants that achieved partial response (PR), complete response (CR), or stable disease (SD) after treatment among total number of evaluable patients.	Up to 24 months post infusion
Progression-free survival (PFS)	To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.	Up to 24 months post infusion
Duration of Response (DoR)	To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.	Up to 24 months post infusion
Overall survival (OS)	To evaluate the time from the date of TIL infusion to death due to any cause.	From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first)

Collaborators and Investigators

• Sponsor: Grit Biotechnology
• Collaborators: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Immunologic; Toll-Like Receptors; Receptors, Pattern Recognition; Toll-Like Receptor 1
• Other Study ID Numbers: GRIT-CO-FA-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No