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

Phase 1

Recruiting

• Conditions: Advanced Clear Renal Cell Carcinoma; Adult
• Interventions: Biological: IB-T101 injection

• Registration Number: NCT06819293
• Lead Sponsor: Grit Biotechnology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-06
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-12-07
• Study Completion: 2027-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IB-T101 injection treatment group	IB-T101 injection	-

Primary Outcome Measures

Name	Time	Method
AEs	3 years	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
Objective response rate	3 years	To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater

Trial Locations

Locations (1)

Tongji hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China