Verismo Therapeutics has commenced the first patient dosing in its multicentre Phase I CELESTIAL-301 trial of SynKIR-310.
The subject was dosed at the Sarah Cannon Research Institute of Colorado Blood Cancer Institute in Denver, Colorado, US.
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Designed to assess the therapy’s tolerability, preliminary efficacy, and safety in individuals with various subtypes of relapsed/refractory B cell Non-Hodgkin Lymphomas (B cell NHL), the trial is set to enrol subjects who have either relapsed after CAR T therapy or have never received it.
Subjects will be divided into two cohorts, with each cohort consisting of three to six individuals, to assess the therapy’s safety and feasibility.
Dose escalation will be conducted across the cohorts to establish a Recommended Phase II Dose (RP2D). Following this, a dose expansion group will be formed recruiting additional subjects to further evaluate the therapy at the RP2D, regardless of B-NHL subtype.
Verismo Therapeutics chief operations officer and chief scientific officer Dr Laura Johnson said: “The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected.
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By GlobalData“SynKIR-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients.”
Leveraging the company’s KIR-CAR platform and proprietary CD19 binder DS191, SynKIR-310 targets CD19, which is a common target in approved CAR T therapies with the potential for “prolonged anti-tumour T cell function and persistence”.
A multi-chain CAR T cell therapy, the KIR-CAR platform claims to have demonstrated the ability to maintain antitumor T cell activity in challenging tumour microenvironments in preclinical animal models.
In May last year, the US Food and Drug Administration (FDA) granted investigational new drug (IND) clearance for SynKIR-310, allowing the company to proceed with this trial.
SynKIR-310 is said to be the second clinical pipeline candidate from the company, following SynKIR-110, which targets aggressive mesothelin-expressing solid tumours.
