Status:
RECRUITING
TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Lead Sponsor:
Grit Biotechnology
Collaborating Sponsors:
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Solid Tumors, Adult
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 1\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;
- Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
- 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
- 1\. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
- 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;
- 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;
- 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);
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06088472
Start Date
April 21 2021
End Date
December 31 2027
Last Update
September 29 2025
Active Locations (1)
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1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000