GT101 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 GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430373
• Other study ID #: GT101-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Grit Biotechnology
• Contact: Haifeng Qin, PhD
• Phone: +86 13601365243
• Email: hifo[@]263.net
• 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.

The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes：

1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).

2. GT101 infusion.

3. post-infusion treatment (interleukin-2 intravenous push).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• 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:
• GT101
Autologous tumor infiltrating lymphocyte injection

Locations

Country	Name	City	State
China	The fifth medical center of the General Hospital of the Chinese people's Liberation Army	Beijing	Beijing
China	West China School of Medicine/West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Center	Chongqing	Chongqing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

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 TEAEs	To characterize the safety profile of autologous TIL injection(GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade = 3 treatment-emergent adverse events (TEAEs)	3 years
Primary	Objective response rate	To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator	3 years
Primary	Progression-free survival	To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator	3 years
Primary	Overall survival	To evaluate efficacy parameters such Overall Survival (OS)	3 years