Injection of immune cells to treat advanced solid tumors

Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors

This study is testing a new treatment that uses immune cells from patients' own tumors to see if it can help people with advanced solid tumors feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, cyclophosphamide, fludarabine
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05430360 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial evaluates the safety and efficacy of autologous tumor-infiltrating lymphocyte therapy for patients with metastatic or recurrent advanced solid tumors. The approach involves a regimen of lymphodepleting chemotherapy followed by the infusion of autologous tumor-infiltrating lymphocytes and interleukin-2. The study will enroll 30 subjects, with a focus on those who have accessible tumor tissue for lymphocyte preparation. Participants will undergo a structured process including screening, treatment, and follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are patients with metastatic or recurrent advanced solid tumors who have accessible tumor tissue and an ECOG performance status of 0 or 1.

Not a fit: Patients with uncontrolled tumor-related pain, significant respiratory diseases, or those who have not responded to prior surgeries or radiation therapy 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 who have limited treatment alternatives.

How similar studies have performed: While this approach is being explored in various contexts, the specific application of autologous tumor-infiltrating lymphocyte therapy in this manner is relatively novel.

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; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.

Where this trial is running

Hangzhou, Zhejiang

• The First Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Weijia Fang, PhD

Conditions Solid Tumor