TIL Injection for the Treatment of 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 is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, clear lung pretreatment period, treatment and observation period, and follow-up period.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors, Adult
• Intervention / Treatment: Biological: TIL injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zhengxiang Han, PhD; Phone Number: +86 18052268612; Email: cnhzxyq@163.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Zhengxiang Han, PhD; Phone Number: +86 18052268612; Email: cnhzxyq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
• 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. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
• 4.Any anti-tumor therapy should be stopped at least 28 days before NMA lymphodepletion pretreatment;

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);
• 3. Arterial/venous thrombotic events within 5 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, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
• 6. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same
• 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 8.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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIL injection treatment group	Biological: TIL injection; Autologous tumor infiltrating lymphocyte injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile Measured by Grade ≥3 TRAEs	Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0	3 years

Collaborators and Investigators

• Sponsor: Grit Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Estimated): April 21, 2024
• Study Completion (Estimated): April 21, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GRIT-CO-FA-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No