Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Samer A Srour, MB ChB, MS
CONTACT
Lead
M.D. Anderson Cancer Center
Primary Objectives: * To determine the occurrence of dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of LNK001 CAR T cells in patients with advanced clear cell RCC (ccRCC) to inform the selection of the recommended dose for expansion (RDE)/optimal cell dose (OCD). * To assess the safety and tolerability of LNK001 in participants with advanced ccRCC. Secondary Objective: • To assess measures of anti-tumor efficacy, including the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) after LNK001 infusion. Although the clinical benefit of LNK001 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Exploratory Objectives: * To characterize pharmacokinetics and pharmacodynamics of LNK001 (CAR T-cell levels, cytokine profiles, anti-drug antibodies). * To assess baseline tumor molecular features (CAIX/ENPP3) and correlate with response. * To identify predictive biomarkers of safety and efficacy.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
