GT201 Injection For The Treatment Of Advanced Solid Tumors

NCT06144671 | Recruiting Phase 1

• 1 other identifier: GT-CD-CHN-201-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Safety Profile Measured By Grade ≥ 3 TREAs

  Safety Profile Measured By Grade ≥ 3 TREAs for CTCAE 5.0

  3 years

Secondary Outcomes (1)

• Tumor imaging to determine changes in tumor size

  3 years

Study Arms (1)

GT201 treatment group

EXPERIMENTAL

GT201 5E9（5×10\^9）;GT201 1E10（1×10\^10）;GT201 5E10（5×10\^10）.

Drug: GT201

Interventions

GT201 DRUG

Autologous tumor infiltrating lymphocyte injection

GT201 treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies;
• 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 ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible.

You may not qualify if:

• 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);
• \. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• \. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
• \. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;
• \. 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).

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (4)

The fifth medical center of the General Hospital of the Chinese people's Liberation Army

Beijing, Beijing Municipality, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Central Study Contacts

Yongsheng Wang, PHD

CONTACT

+86 18980602258; wangys@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 22, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 13, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (4)