TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Solid Tumors, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088472
• Other study ID #: GRIT-CO-FA-012
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 21, 2021
• Est. completion date: April 21, 2024

Study information

• Verified date: October 2023
• Source: Grit Biotechnology
• Contact: Zhengxiang Han, PHD
• Phone: +86 18052268612
• Email: cnhzxyq[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 21, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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);

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors, Adult

Intervention

Biological:
• TIL injection
Autologous tumor infiltrating lymphocyte injection

Locations

Country	Name	City	State
China	The Affiliated Hospital Of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile Measured by Grade =3 TRAEs	Safety Profile Measured by Grade =3 TRAEs by CTCAE 5.0	3 years