GT101 injection for treating metastatic or recurrent solid tumors

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

This study is testing a new treatment called GT101 to see if it can help people with hard-to-treat metastatic or recurrent solid tumors feel better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (industry)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, prednisone, chemotherapy
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT05430373 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm phase I clinical trial aims to evaluate the safety and efficacy of GT101, an autologous tumor-infiltrating lymphocyte therapy, for patients with unresectable recurrent or metastatic solid tumors. The study involves a screening period, lymphodepleting chemotherapy, GT101 infusion, and post-infusion treatment with interleukin-2. A total of 20-31 subjects will be enrolled, with 14-20 expected to be evaluable for treatment outcomes. The trial will assess the response of the tumors to this innovative therapy.

Who should consider this trial

Good fit: Ideal candidates include adults with unresectable recurrent or metastatic solid tumors who have at least one resectable lesion for lymphocyte preparation.

Not a fit: Patients with solid tumors that are resectable or have received prior local therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat metastatic or recurrent solid tumors.

How similar studies have performed: While this approach is innovative, similar therapies have shown promise in other studies, indicating potential for success.

Eligibility criteria

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);

Where this trial is running

Beijing, Beijing Municipality and 4 other locations

• The fifth medical center of the General Hospital of the Chinese people's Liberation Army — Beijing, Beijing Municipality, China (RECRUITING)
• Chongqing University Cancer Center — Chongqing, Chongqing Municipality, China (RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• West China School of Medicine/West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Haifeng Qin, PhD

Conditions: Solid Tumors, Adult