Injection of immune cells for advanced solid tumors

A Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

This study is testing whether injecting patients with their own immune cells can help treat advanced solid tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, cyclophosphamide, fludarabine
• Locations: 4 sites (Zhengzhou, Henan and 3 other locations)
• Trial ID: NCT05729399 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of autologous tumor-infiltrating lymphocyte therapy in patients with advanced solid tumors. Participants will undergo a regimen that includes lymphodepleting chemotherapy followed by the infusion of their own tumor-infiltrating lymphocytes and interleukin-2. The study is designed as a multi-center, single-arm phase I trial, aiming to enroll 26 to 42 subjects. The process involves several phases including screening, treatment, and follow-up to assess the therapy's safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced solid tumors who have accessible tumor tissue and meet specific health criteria.

Not a fit: Patients with uncontrolled tumor-related pain or those who have not responded to prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced solid tumors.

How similar studies have performed: Other studies using similar autologous immune cell therapies have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

  2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.

  3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion Criteria:

* 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.

  2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.

  5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .

  6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;

Where this trial is running

Zhengzhou, Henan and 3 other locations

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhengxiang Han, PhD

Conditions Solid Tumor