GT101 injection for treating advanced solid tumors

A Single Center, Single Arm Phase I Clinical Study of GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

This study is testing a new injection treatment for people with advanced solid tumors that can't be surgically removed to see if it helps them feel better.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (industry)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06077903 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-center, single-arm phase I intervention that aims to treat patients with unresectable recurrent or metastatic solid tumors using GT101 injections. The protocol includes a chemotherapy pretreatment followed by the reinfusion of autologous tumor-infiltrating lymphocytes and interleukin-2 injections. The study plans to enroll 20 subjects to evaluate the safety and efficacy of this treatment approach. Participants will be closely monitored for responses and any adverse effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with unresectable recurrent or metastatic solid tumors who have at least one resectable lesion.

Not a fit: Patients with solid tumors that have been previously treated with radiation or 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 advanced solid tumors that are difficult to treat.

How similar studies have performed: While this approach is novel, similar studies using tumor-infiltrating lymphocytes have shown promise in treating various cancers.

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 Volume ≥1cm\^3 (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.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;
* 3. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
* 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 5.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

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Yi Zhang, PHD

Conditions: Adult