A Phase 1 Study Of LNK001 (Dual ENPP3/CAIX AND-gate CAR T Cell Therapy) In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCyclophosphamide
Given by IV
- DrugFludarabine
Given by IV
- DrugLNK001
Given by infusion
Location
- UT MD AndersonHouston, Texas