2026.03.04
CureGenetics, a clinical-stage biotechnology company pioneering chimeric antigen receptor natural killer T (CAR-NKT) Cell therapies for solid tumors and immune-mediated diseases, today announced encouraging clinical data from an investigator-initiated Phase I trial of CGC729.
This novel anti-CD70 CAR-NKT cell therapy is being evaluated in patients with relapsed/refractory metastatic clear cell renal cell carcinoma (ccRCC), a population with limited treatment options and high unmet needs. Approximately 55–60% of first-line patients go on to the subsequent lines of therapy. Moreover, higher-efficacy treatments such as tyrosine kinase inhibitor (TKI)- and immuno-oncology (IO)-based therapies are often associated with significant side effects, underscoring the need for safer and more durable options in this setting.
The updated dataset includes additional patient enrollment and extended follow-up, building upon data previously presented as a late-breaking abstract at the 2024 ASGCT Annual Conference. CGC729 continues to demonstrate a favorable safety profile and promising efficacy signals in heavily pretreated ccRCC patients.
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Clinical Findings (as of January 2026)
· Ten patients with mRCC who were heavily pretreated (>2 prior lines) received single infusions of CGC729 following standard lymphodepletion.
· No dose-limiting toxicities (DLTs) and no grade ≥3 (cytokine release syndrome) CRS or (immune effector cell-associated neurotoxicity syndrome) ICANS were observed. Unlike the anemia and hypoxia commonly associated with HIF2α inhibitors (≥Grade 3 in 20–30% and 7–21%, respectively) or the high rate of ≥Grade 3 adverse event (AE) seen with TKI monotherapy, CGC729 showed a notably clean safety profile. Importantly, no overlapping toxicities were observed with IO-, TKI-, or HIF-2α–based therapies.
· Overall response rate (ORR) of 30% (3/10) and disease control rate (DCR) of 60% (6/10) across all evaluable patients.
· In CD70-positive patients, ORR reached 33.3% (3/9), with tumor reductions of up to 80%.
· Responses were observed even in low CD70 expression tumors (CD70 H-score<100 or TPS <50%), suggesting strong sensitivity and tumor penetration.
· CGC729 demonstrated robust in vivo expansion and persistence up to Week 20, accompanied by durable reduction in circulating CD70⁺ T cells.
· A patient in Dose Level 1 with a CD70 H-score of 50 maintained a partial response through Week 65, underscoring the durability of the CAR-NKT cell approach.
· One patient in Dose Level 3 achieved stable disease through Week 52.
These results compare favorably with other anti-CD70 CAR-T therapies in ccRCC, including reported ORRs of 27% (no objective response in CD70 TPS<50% patients) for Allo-316 and 6.7% for CTX130 in CD70-positive patients.
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Differentiated Advantages of the CAR-NKT Platform
CureGenetics’ CAR-NKT cell therapy platform harnesses both innate and adaptive immune properties to address key limitations of traditional CAR-T cell therapies:
● Tumor infiltration: NKT cells naturally home to inflamed tissues and solid tumors, enhancing tumor accessibility.
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Platform Expansion and Strategic Outlook
Building on these early results, CureGenetics is advancing its proprietary CAR-NKT cell therapy platform beyond CD70-targeted ccRCC to additional solid tumors and autoimmune diseases. The core of this strategy is the development of scalable, off-the-shelf allogeneic CAR-NKT cell products, designed to address the logistical and manufacturing constraints of autologous cell therapies.
“Our Phase I data demonstrate that CAR-NKT cells can safely and effectively target solid tumors, an area where traditional CAR-T therapies have faced challenges,” said Yuanyuan Xu, Chairman and CEO of CureGenetics. “We are developing a platform that is not only biologically differentiated, but also scalable and commercially viable.”
CureGenetics’allogeneic CAR-NKT approach leverages the semi-invariant TCR of NKT cells to minimize alloreactivity, enabling the use of universal donors and streamlined manufacturing. The design positions the platform for rapid deployment across multiple indications, lower cost of goods, and improved patient accessibility.
CureGenetics is a clinical-stage biotechnology company developing next-generation cell therapies. Its proprietary NKT-cell platform is designed to deliver safer, more potent, and broadly applicable cellular immunotherapies across oncology and immune-related diseases.
