Data from ANTLER presented during the 2022 EHA Congress show initial findings of CB-010 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
Clinical data from the phase 1 ANTLER clinical trial (NCT04637763) of CB-010 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) have been presented in poster at the European Hematology Association (EHA) 2022 Congress on, according to Caribou Biosciences, Inc.
The additional initial data will include longer duration data on the 6 patients treated at dose level 1, based on a new data cutoff date.
CB-010 is an allogeneic anti-CD19 CAR T-therapy which was made using Cas9 CRISPR hybrid RNA-DNA technology. It is the first allogeneic CAR T-cell therapy and lead product candidate from Caribou Bioscience’s CAR T-cell therapy platform, which works to insert a CD19-specific CAR into the TRAC gene and get rid of PD-1 to boost the persistence of antitumor activity. CB-010 is the first in the clinic with a PD-1 knock out.
The first-in-human, phase 1, multicenter, open-label ANTLER trial aims to evaluate the safety and efficacy of CB-010 in an estimated 50 adult patients with relapsed/refractory B-cell NHL. Additionally, both pharmacokinetics and immunogenicity of CB-010 in this patient population after lymphodepletion consisting of cyclophosphamide and fludarabine will be examined.
The study consists of 2 parts including the dose escalation portion of the trial (part A), and the dose expansion portion of the trial (part B). The dose escalation part of the trial will follow a 3 + 3 design, with sequential, prespecified, increasing doses and patients with relapsed/refractory NHL will receive CB-010 following lymphodepletion. Within the dose expansion part, patients will receive CB-010 at the determined dose from part A.
Eligibility in the trial is open to patients aged 18 years and older at the time of enrollment with a documented diagnosis of relapsed or refractory NHL after they have received prior standard of care. Additionally, patients must have an ECOG performance status of 0 or 1, as well as adequate hematologic, renal, liver, cardiac, and pulmonary organ function.
Participants with prior therapy with an anti-CD19 targeting agent, active or chronic graft versus host disease requiring therapy, prior allogeneic stem cell transplantation, or central nervous system (CNS) lymphoma or prior CNS malignancy will be excluded from the trial.
Those with a prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement, primary immunodeficiency, a current or expected need for systemic corticosteroid therapy, or a current thyroid disorder will also be excluded from the trial. Further, those diagnosed with any other malignancy between 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence, will be ineligible to enroll.
In part A of the trial, the primary end point is the incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion. The primary end point for part B is objective response rate with a time frame of up to 12 months.
With an estimated completion date of September 2025, the ongoing study is actively recruiting patients in 4 states, including Arizona, California, Ohio, and Texas.