Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06819293

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Clear Renal Cell Carcinoma Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tongji hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

IB-T101 injection

Biological

IB-T101 injection to treat advanced clear renal cell carcinoma

Primary outcomes

  1. Objective response rate

    Time frame: 3 years

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

  2. AEs

    Time frame: 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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Registry information

Official study title

A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.