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NCT Number: NCT05430373

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

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

Recruiting

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Key information

Conditions

Solid Tumors, Adult

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The fifth medical center of the General Hospital of the Chinese people's Liberation Army, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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;
  • 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. 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;

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);
  • 3. Arterial/venous thrombotic events within 6 months prior to surgical operation, 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, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
  • 6. 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;
  • 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
  • 8.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);

Treatment and study plan

GT101

Biological

Autologous tumor infiltrating lymphocyte injection

Primary outcomes

  1. Safety Profile Measured by Grade ≥3 TEAEs

    Time frame: 3 years

    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)

  2. Objective response rate

    Time frame: 3 years

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

  3. Overall survival

    Time frame: 3 years

    To evaluate efficacy parameters such Overall Survival (OS)

  4. Progression-free survival

    Time frame: 3 years

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

  5. Disease Control Rate

    Time frame: 3 years

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

  6. Duration of Response

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Qin, PhD

CONTACT

[email protected]

+86 13601365243

Yongsheng Wang, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Registry information

Official study title

A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 24, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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