Phase I/II Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors

NCT06144671 | Recruiting Phase 1

• 1 other identifier: GT-CD-CHN-201-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Adverse events (AEs)

  Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 1)

  Up to 2 years

• Changes in laboratory parameters

  Evaluate the safety and tolerability based on changes in laboratory parameters before and after treatment. (Phase 1)

  Up to 2 years

• Objective Response Rate (ORR)

  Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 2).

  Up to 2 years

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression free survival (PFS)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

GT201 treatment group

EXPERIMENTAL

The treatment groups consist of monotherapy and combination therapy with PD-1. The monotherapy treatment is lymphodepleting chemotherapy followed by infusion of GT201 injection and IL-2. The combination therapy is lymphodepleting chemotherapy followed by infusion of GT201 injection and IL-2, along with continuous administration of PD-1 inhibitor therapy.

Biological: GT201; Biological: IL-2; Biological: PD-1 inhibitor

Interventions

GT201 BIOLOGICAL

Infusion

GT201 treatment group

IL-2 BIOLOGICAL

Injection

GT201 treatment group

PD-1 inhibitor BIOLOGICAL

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:

• \. Voluntarily enroll in the study, sign the informed consent form (ICF), and be willing and able to comply with the study protocol.
• \. Aged 18 to 70 years old. For subjects older than 70 years old, eligibility shall be jointly determined by the Investigator and the Sponsor's Medical Monitor.
• \. Diagnosis:
• Phase I trial: Patients with advanced solid tumors who have failed standard therapy, have no available standard therapy, or cannot tolerate standard therapy.

You may not qualify if:

• \. At least one lesion that is resectable for the preparation of autologous TIL cells.
• \. At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• \. Estimated survival time ≥ 12 weeks.
• \. Functions of major organs meet the requirements specified in the protocol.
• \. Female or male subjects of childbearing potential who have not undergone surgical sterilization must agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for 1 year after the end of study treatment. For female subjects of childbearing potential without surgical sterilization, serum human chorionic gonadotropin (hCG) test must be negative within 7 days prior to cell infusion.
• \. Prior treatment related adverse events shall have recovered to Grade ≤ 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 before tumor sampling, or be judged by the investigator together with the sponsor's medical monitor not to interfere with the study.
• \. For participants enrolled in this study due to disease progression, imaging documentation confirming disease progression following the prior therapy must be available before tumor sampling.
• \. Patients with spinal cord compression not relieved by surgery and/or radiotherapy are excluded. (Patients may be enrolled if clinical evidence confirms symptom relief for ≥ 1 week prior to tumor harvesting.)
• \. Participants with uncontrolled tumor related pain as judged by the investigator. Participants requiring analgesic medications must have a stable analgesic regimen at study entry. Symptomatic lesions suitable for palliative radiotherapy should have completed treatment prior to study entry.
• \. Bleeding events within 3 months prior to screening.
• \. Patients with arterio-venous thrombotic events that occurred within 6 months prior to screening.
• \. Respiratory disorders that severely impair pulmonary function at screening.
• \. History of clinically significant cardiovascular disease, including but not limited to:
• Congestive heart failure (New York Heart Association \[NYHA\] Class \>grade II);

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (2)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Interventions

Interleukin-2; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Yue He, PhD

CONTACT

+86- 13501950200; william5218@126.com

Study Design

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

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 22, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

CN (2)