M.D. Anderson Cancer Center
There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC. The goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.
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 o…
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed metastatic/advanced RCC with a clear cell component who have received at least one prior line of systemic treatment in the advanced or metastatic setting, including at least one PD-1/PD-L1 immune checkpoint inhibitor (ICI) and one tyrosine kinase inhibitor (TKI). Patients with locally advanced disease who are eligible for curative resection are excluded. • For patients who received one prior line of therapy, they must have had evidence of disease progression. For patients who received 2 or more prior lines of t…
Given by IV
Given by IV
Given by infusion
Arctuva estimate
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