Adult, Advanced Clear Renal Cell Carcinoma
Conditions
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
Interventions
BIOLOGICALIB-T101 injection
IB-T101 injection to treat advanced clear renal cell carcinoma
Sponsors
Grit Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 years | To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater |
| 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 |
Countries
China
Contacts
CONTACTBo Liu
Outcome results
None listed