Philadelphia, Pennsylvania, United States, November 4, 2026
Verismo Therapeutics has announced promising first-in-human clinical findings from its ongoing Phase 1 CELESTIAL-301 study evaluating SynKIR™-310, an investigational CD19-targeted KIR-CAR T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). The preliminary results showed an 80% objective response rate (ORR) and a 60% complete response rate among evaluable patients treated in the first two dose cohorts. The company also reported that no cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or dose-limiting toxicities (DLTs) occurred among the six patients treated at these dose levels. These findings will be featured in an oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting, scheduled for December 12–15, 2026, in New Orleans, Louisiana. The results highlight the potential of Verismo’s multi-chain KIR-CAR platform as an alternative approach to conventional CAR T-cell engineering.
SynKIR-310 Demonstrates Early Antitumor Activity
The CELESTIAL-301 Phase 1 clinical trial is an ongoing multicenter, first-in-human dose-escalation study investigating the safety, feasibility and preliminary efficacy of SynKIR-310 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. The study is designed for patients whose disease has returned or failed to respond after at least two previous lines of treatment, representing a population with significant unmet medical needs. At the July 14, 2026, data cutoff, six patients had received SynKIR-310, with three patients treated in each of the first two dose cohorts. Five patients were evaluable for treatment response. Among these five participants, four achieved an objective response, producing an 80% ORR, while three achieved complete response, corresponding to a 60% complete response rate. The median time to response was approximately one month. Importantly, the median duration of response among patients achieving complete response had not been reached at the data cutoff. One patient remained in complete response at the 12-month assessment, indicating a sustained response in that individual. The study included patients with different B-cell lymphoma subtypes, including aggressive and indolent disease. All six participants had advanced-stage disease, and several had high-risk molecular characteristics. These preliminary findings provide an early clinical signal, although the small number of evaluable patients means that larger studies and longer follow-up are necessary to confirm the treatment’s effectiveness.
No CRS or ICANS Reported in Initial Dose Cohorts
A notable finding from the initial clinical assessment was the reported absence of CRS and ICANS of any grade among all six treated patients in dose cohorts one and two. The company also reported no dose-limiting toxicities and no serious adverse events considered related to SynKIR-310. Treatment-related adverse events reported in individual patients included headache, fatigue, hypogammaglobulinemia, decreased neutrophil count and decreased white blood cell count. Some blood-cell count reductions were classified as Grade 4, highlighting the importance of continued safety monitoring during dose escalation. Three of the six patients received their SynKIR-310 treatment in an outpatient setting, an observation that may be relevant to future treatment delivery if the safety profile is maintained in larger patient populations. CAR T-cell therapies can produce significant immune-related complications, particularly CRS and neurological toxicity. These events can require specialized monitoring and hospital-based management. Therefore, the early absence of these toxicities is an encouraging observation. However, it should not be interpreted as proof that SynKIR-310 eliminates CAR T-associated risks, especially because only six patients had been treated at the initial dose levels.
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Novel Multi-Chain KIR-CAR Technology Advances Development
SynKIR-310 uses Verismo’s proprietary multi-chain killer immunoglobulin-like receptor (KIR)-based CAR technology, which is designed to separate tumor recognition from T-cell activation. The therapy targets CD19, a protein expressed on the surface of many B-cell malignancies. Unlike conventional single-chain CAR T-cell designs, SynKIR-310 uses a modified natural killer cell-derived KIR receptor paired with the DAP12 signaling protein. This approach is intended to provide a regulated activation mechanism, potentially reducing excessive background signaling and supporting T-cell persistence and function. At ASH 2026, Verismo plans to present updated clinical and pharmacokinetic/pharmacodynamic data covering dose cohorts one through three. The company will also present two preclinical posters, including research on a CD19/CD20 dual-targeted KIR-CAR construct designed to address tumor antigen variability and a comparison of multi-chain SynKIR-310 with conventional single-chain CAR T designs. Overall, the preliminary CELESTIAL-301 findings represent an important milestone in next-generation CAR T-cell development. Further patient enrollment, dose escalation and longer-term follow-up will be essential to establish SynKIR-310’s safety, durability and potential clinical benefit in relapsed or refractory B-cell lymphoma.
Source: Verismo Therapeutics press release
