Curocell announced on the 30th that it has filed an application with the Ministry of Food and Drug Safety (MFDS) for approval of amendments to the Phase 3 clinical trial plan (IND) for CRC01 (anbacaptagene autoleucel, product name 'Anbalsel'), a treatment candidate for relapsed or refractory adult large B-cell lymphoma.

Additional clinical trial aimed at comparing with standard-of-care in approximately 136 patients

The amendment application is intended to add a clinical trial. It covers a trial comparing the efficacy and safety of CRC01 versus standard of care (SOC) in patients with relapsed or refractory adult large B-cell lymphoma. The trial will be conducted as an open-label, multi-center, randomized study at Samsung Medical Center and other institutions in Korea. The target number of subjects is approximately 136 in total, with about 68 patients to be assigned to each of the CRC01 treatment group and the standard-of-care group.

Primary endpoint is event-free survival (EFS)

The primary objective of the clinical trial is to evaluate event-free survival (EFS) in the CRC01 treatment group compared to the standard-of-care group. Secondary objectives include comparing the efficacy and safety of the two treatment groups. Subjects will be randomly assigned to receive each treatment and then followed up for 36 months.

For the standard-of-care group, CRC01 administration may be considered if the disease progresses, if complete or partial remission is not achieved by nine weeks after randomization, or if new antineoplastic treatment must be initiated after 18 weeks due to concerns about insufficient efficacy.

Trial period of approximately 60 months... first approved in 2021

The clinical trial period is approximately 60 months from the approval date of the MFDS and the Institutional Review Board (IRB), and may vary depending on subject enrollment.

According to Curocell, the clinical trial plan was initially submitted for approval on September 4, 2020, and approved on February 18, 2021. At the time, the company had not yet been listed on the KOSDAQ market, so no related disclosure was filed. The company stated that if it receives approval for the amended clinical trial plan, it will immediately disclose the relevant details.

Statistical probability of approval approximately 10%... possibility of changes to commercialization plans

Meanwhile, Curocell disclosed that the statistical probability of the clinical trial drug ultimately receiving approval as a drug is known to be approximately 10%. It also stated that outcomes during the clinical trial and product approval process may fall short of expectations, and that it may accordingly change or abandon its commercialization plans.