GT201 injection for advanced solid tumors

A Single-Arm Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors

This study is testing a new injection called GT201 to see if it can safely help people with advanced solid tumors who haven't had any local treatments before.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (industry)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, prednisone
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06144671 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of GT201 injection in patients with advanced solid tumors. It employs a modified '3+3' dose-escalation design, which includes both accelerated dose escalation and traditional methods. The trial aims to enroll 7 to 18 evaluable subjects across three dose groups, with the first group undergoing accelerated titration and the subsequent groups following the traditional escalation principle. The study focuses on patients with resectable lesions who have not received prior local therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of advanced solid tumors and at least one resectable lesion.

Not a fit: Patients with active autoimmune diseases or those who 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 advanced solid tumors.

How similar studies have performed: Other studies utilizing similar dose-escalation approaches have shown promise, but this specific treatment is novel.

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;
* 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 ≥1.0cm\^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.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);
* 2\. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 3\. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
* 4\. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;
* 5\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 6.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 3 other locations

• The fifth medical center of the General Hospital of the Chinese people's Liberation Army — Beijing, Beijing Municipality, China (RECRUITING)
• Union Hospital Tongji Medical College Huazhong University Of Science And Technology — Wuhan, Hubei, China (RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Yongsheng Wang, PHD

Conditions: Solid Tumor, Adult