NEW YORK – Oncternal Therapeutics on Wednesday began treating patients with B-cell lymphomas in a Phase I/II trial of its ROR1-targeting autologous CAR T-cell therapy, ONCT-808.
Researchers will enroll up to 57 patients in the trial with relapsed or refractory aggressive B-cell malignancies including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). The Phase I dose-escalation portion of the study will enroll one cohort of patients with these B-cell lymphomas, while the Phase II portion will enroll LBCL and MCL patients into separate dose-expansion cohorts. The trial will also include patients who have failed previous CD19 CAR T-cell therapy.
Oncternal, based in San Diego, partnered with the Karolinska Institute in Sweden in 2021 to develop ROR1-targeting cell therapies including ONCT-808. The firm is also developing zilovertamab, a ROR1-targeted monoclonal antibody, for the treatment of blood cancers and solid tumors.
"We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma," Oncternal CEO James Breitmeyer said in a statement. "It builds on our extensive clinical experience with zilovertamab, as well as that with zilovertamab vedotin, an antibody-drug conjugate, which has shown that ROR1 can be targeted without unwanted off-tumor, on-target activity."