CGC729 / Cure Genetics - LARVOL DELTA

Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024 (PRNewswire-Asia) - "This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of CGC729....Among four eligible patients, the overall response rate (ORR) reached 50% (2/4). Among CD70 positive patients (n=3),ORR was 66.7% (2/3), with two patients achieving partial response (PR). CGC729 demonstrated promising efficacy with deep anti-tumor activity. The longest duration of response (DOR) is continuing at nine-month after treatment."

P1 data • Renal Cell Carcinoma

Interim Safety and Efficacy of Anti-CD70 CAR-NKT (CGC729) for Patients with Refractory Metastatic Renal Cell Carcinoma (ASGCT 2024) - P1 | "2024, five patients who received at least 2 prior lines of therapy were enrolled and treated with a single infusion of CGC729 following a 3-day lymphodepletion regimen (fludarabine 25mg/m2/day; cyclophosphamide 250mg/m2/day)...Patient 0102 in DL1 was RCC CD70- and experienced progress disease (PD) on Day 28... Interim analysis of this first-in-human trial of anti-CD70 CAR-NKT demonstrates a manageable safety profile and promising antitumor activity for the treatment of refractory metastatic RCC. Figure 1: CGC729 had deep anti-tumor activity (A) accompanied with robust expansion and durable persistence (B) in DL1."

Clinical • Late-breaking abstract • Metastases • Genito-urinary Cancer • Hematological Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

Interim Safety and Efficacy of Anti-CD70 CAR-NKT (CGC729) for Patients with Advanced Renal Cell Carcinoma (ASGCT 2024) - P1 | "2024, five patients who received at least 2 prior lines of therapy were enrolled and treated with a single infusion of CGC729 following a 3-day lymphodepletion regimen (fludarabine 25mg/m2/day; cyclophosphamide 250mg/m2/day)...Among four patients evaluable for PK, robust CAR-NKT expansion in the peripheral blood was observed in all patients including Patient 0102 who had negative CD70 expression in ccRCC... Interim analysis of this first-in-human trial of anti-CD70 CAR-NKT demonstrates a manageable safety profile and promising antitumor activity for the treatment of advanced ccRCC. Figure 1: CGC729 had deep anti-tumor activity (A) accompanied with robust expansion and durable persistence (B) in DL1. Plain Language Summary: We have been developing a new therapy (CAR-NKT) for advanced kidney cancer patients by engineering one type of patient's own immune cells, called natural killer T (NKT) cells."

Clinical • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hematological Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Fudan University

Metastases • New P1 trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor