Tumor-infiltrating lymphocyte (TIL) injection for metastatic or recurrent solid tumors

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

This trial will try using a patient's own tumor-infiltrating lymphocytes (TILs), given after short chemotherapy, to see if they can help control metastatic or recurrent solid tumors in adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, cyclophosphamide, fludarabine, prednisone
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT06088472 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm Phase 1 trial that collects a resectable tumor sample to grow autologous tumor-infiltrating lymphocytes for infusion. The process includes screening, tumor sampling and TIL production, a short non‑myeloablative low-dose (NMA‑LD) chemotherapy period, TIL infusion with subsequent observation, and planned follow-up. Eligible patients must have unresectable recurrent or metastatic solid tumors and at least one resectable lesion (≥0.5 cc) suitable for TIL production. Key exclusions include symptomatic or untreated brain metastases and active autoimmune disease or history requiring immunosuppression.

Who should consider this trial

Good fit: Adults with unresectable recurrent or metastatic solid tumors who have at least one untreated, resectable lesion large enough for TIL harvest and who meet overall health and safety criteria are the best candidates.

Not a fit: Patients without a suitable lesion to harvest, those with active autoimmune disease, or those with symptomatic/untreated CNS metastases are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could shrink tumors or delay progression by using the patient's own immune cells to attack cancer.

How similar studies have performed: Autologous TIL therapy has produced notable durable responses in melanoma and shown promise in other cancers, but its effectiveness across many metastatic solid tumors remains experimental.

Eligibility criteria

Inclusion Criteria:

* 1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
* 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, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated 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) within 14 days before lymphocyte depletion chemotherapy;
* 3\. Arterial/venous thrombotic events within 6 months prior to enrollment, 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, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
* 6\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 7.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

Xuzhou, Jiangsu

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhengxiang Han, PHD

Conditions Solid Tumors, Adult