IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrit Biotechnology
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
IB-T101 injection
Biological/VaccineIB-T101 injection to treat advanced clear renal cell carcinoma
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: IB-T101 injection treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate
To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater
Time frame
3 years2
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
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov