LNK001 Dual-Target CAR T Cells

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.

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.

Live record on ClinicalTrials.gov →

• 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 therapy, evidence of progression is not required if they stopped treatment for intolerance.
• Confirmation of CAIX expression ≥ 50% at any intensity (greater than 0) by immunohistochemistry staining of the patient's primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study. Both overall extent of expression and staining intensity will be scored. Archival tissues that exist prior to the time of enrollment will be used for this purpose.
• Patients must have at least one measurable site of disease per RECIST version 1.1.4.
• ECOG performance status ≤ 1.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.