IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

NCT06819293 | Recruiting Phase 1

• 1 other identifier: GTE-002-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma

Conditions

Adult; Advanced Clear Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater

  3 years

• AEs

  To characterize thesafty profile of autologous TIL injection IB-T101 in patients with advanced fclear renal cell carcinoma as measured by the incidence and severity of adverse events per CTCAE 5.0

  3 years

Study Arms (1)

IB-T101 injection treatment group

EXPERIMENTAL

Biological: IB-T101 injection

Interventions

IB-T101 injection BIOLOGICAL

IB-T101 injection to treat advanced clear renal cell carcinoma

IB-T101 injection treatment group

Eligibility Criteria

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

You may qualify if:

• Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
• Age ≥18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Expected survival time of ≥ 3 months;

You may not qualify if:

• CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.
• Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
• Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
• Pleural effusion requiring drainage for symptom management within 28 days prior to screening

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

Tongji hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Central Study Contacts

Bo Liu

CONTACT

15927168582; liubo0124@163.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: February 5, 2025
• First Posted: February 11, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): December 7, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)