GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

NCT05430373 | Recruiting Phase 1

• 1 other identifier: GT101-101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：

1. 1.Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
2. 2.GT101 infusion.
3. 3.post-infusion treatment (interleukin-2 intravenous push).

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (6)

• Safety Profile Measured by Grade ≥3 TEAEs

  To characterize the safety profile of autologous TIL injection（GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)

  3 years

• Objective response rate

  To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3 years

• Overall survival

  To evaluate efficacy parameters such Overall Survival (OS)

  3 years

• Progression-free survival

  To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

  3 years

• Disease Control Rate

  To evaluate efficacy parameters such disease control rate (DCR) per RECIST 1.1, as assessed by investigater

  3 years

• Duration of Response

  To evaluate efficacy parameters such duration of response (DoR) per RECIST 1.1, as assessed by investigater

  3 years

Study Arms (1)

GT101 treatment group

OTHER

Autologous tumor infiltrating lymphocyte injection

Biological: GT101

Interventions

GT101 BIOLOGICAL

Autologous tumor infiltrating lymphocyte injection

GT101 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:

• \. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
• 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. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) 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);
• \. Arterial/venous thrombotic events within 6 months prior to surgical operation, 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, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
• \. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time;
• \. 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

Study Sites (5)

The fifth medical center of the General Hospital of the Chinese people's Liberation Army

Beijing, Beijing Municipality, 100039, China

RECRUITING

Chongqing University Cancer Center

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

NOT YET RECRUITING

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, 610064, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Central Study Contacts

Haifeng Qin, PhD

CONTACT

+86 13601365243; hifo@263.net

Yongsheng Wang, PhD

CONTACT

wangy756@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: June 13, 2022
• First Posted: June 24, 2022
• Study Start: May 23, 2022
• Primary Completion: September 25, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)