Clinical trial · Interventional
IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
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
NCT06819293CI-TRIAL-00108195recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Advanced Clear Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IB-T101 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IB-T101 injection treatment group
- interventionNames
- Biological: IB-T101 injection
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater
- measure
- AEs
- timeFrame
- 3 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.