CRISPR Therapeutics (NASDAQ: CRSP) has announced updated data from its ongoing Phase 1 CARBON study evaluating CTX110’s efficacy and safety in refractory or relapsed CD19+ B-cell malignancies. CTX110 is the company’s wholly-owned allogeneic CAR-T cell therapy that targets CD19+ B-cell malignancies.
CRISPR shares positive PHASE 1 CARBON study data
CEO Samarth Kulkarni said, “We are excited to share positive data from our CARBON trial, which show that CTX110 could offer patients with large B-cell lymphomas an immediately available ‘off-the-shelf’ therapy with efficacy similar to autologous CAR-T and a differentiated safety profile. Furthermore, we have the potential to improve upon already observed efficacy with a consolidation dosing strategy. Based on these encouraging results, we are planning to expand CARBON into a potentially registrational trial in the first quarter of 2022.”
The Phase 1 CARBON trial is a multicenter, open-label study examining CTX110’s safety and efficacy in patients with refractory or relapsed B-cell CD19+ malignancies that have undergone at least two prior therapy lines. Patients showing aggressive disease presentations, such as diffuse large B-cell lymphoma (DLBCL), high-grade double- or triple-hit lymphomas, not otherwise specified (NOS), and transformed follicular lymphoma, have been prioritized for enrolment so far. Before entering the trial, most of the patients had Stage IV lymphoma and were unresponsive to their final course of treatment. In addition, nine of the patients had previously received an autologous stem cell transplant, with patients that had been given autologous CAR-T not eligible.
The study enrolled 30 patients
Around 30 patients had been enrolled as of the August 26, 2021 data cutoff, with 26 of the subjects receiving CTX110, and 28 follow-up days are part of the analysis. However, one patient didn’t receive CTX110, and three patients had less than 28 follow-up days. Thus they were not included in the analysis.
The was a good tolerability profile across the dose levels without any GvHD cases and no infusion reactions to CTX110 or lymphodepleting chemotherapy.