Oncternal Therapeutics has dosed the first patient in its Phase I/II trial of ONCT-808, a ROR1 targeting autologous CAR T cell therapy, to treat relapsed or refractory aggressive B-cell lymphoma.

The multi-centre, single-arm, open-label, dose escalation/dose expansion ONCT-808-101 study will assess the tolerability, pharmacokinetics, and safety of ONCT-808 in patients with large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and in those who had failed previous CD19 CAR T therapy.

It will also evaluate the anti-tumour activity of the therapy in these subjects.

After determining the recommended Phase 2 dose (RP2D) in Phase I, the Phase II portion will further evaluate the efficacy and safety of ONCT-808 using the RP2D dose.

Subjects in Phase II will be enrolled into two separate dose expansion cohorts.

Initial data from the trial is expected late this year, with additional clinical data readouts anticipated next year.

Oncternal president and CEO James Breitmeyer said: “We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma.

“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.

“We particularly appreciate that this first patient is under the care of Dr Michael Wang, Endowed Professor in the Department of Lymphoma and Myeloma at the MD Anderson Cancer Center in Houston, Texas.”

The Mass General Cancer Center and the Dana-Farber Cancer Institute in Boston, Massachusetts, and the City of Hope Comprehensive Cancer Center in Duarte, California, are the current leading sites for the trial.