TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Official title

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

Overview

This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.

Interventions

• Biological TIL injection
  Autologous tumor infiltrating lymphocyte injection

Primary outcome measures

• Incidence and severity of adverse events per CTCAE 5.0 [Time frame: From TIL infusion to the 24th week]

Secondary outcome measures (5)

• Objective response rate (ORR) [Time frame: Up to 24 months post infusion]
• Disease control rate (DCR) [Time frame: Up to 24 months post infusion]
• Progression-free survival (PFS) [Time frame: Up to 24 months post infusion]
• Duration of Response (DoR) [Time frame: Up to 24 months post infusion]
• Overall survival (OS) [Time frame: From the date of TIL infusion to date of death due to any cause, or up to 24 months post infusion (whichever occurs first)]

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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou

Identifiers

NCT: NCT06088472 · GRIT-CO-FA-012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗