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Anbal-Cel Shows Promising Responses in Large B-Cell Lymphoma

The CD-19 CAR T-cell therapy is developed using Curocell’s OVISTM platform.

Anbalcabtagene autoleucel (anbal-cel; CRC01; Curocell) has demonstrated impressive responses in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) treated in a phase 1/2 study (NCT04836507).1

Findings from the study were presented at the European Hematology Association (EHA) 2022 Congress, June 9-12, held both virtually and in Vienna, Austria, by Wong Seog Kim, MD, PhD, Professor, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.

"Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVISTM platform's potential to maximize CAR-T's functionality to eradicate tumors,” Gunsoo Kim, MS, chief executive officer, Curocell, said in a statement.2

The dose-escalation study is evaluating the safety and preliminary efficacy of anbal-cel in patients with R/R LBCL.1 The study has dosed 11 patients with R/R diffuse LBCL who had received 2 or more prior lines of therapy, 4 of which (36%) had received at least 4 prior lines of therapy. Patients were dosed with 2x105 cells/kg (DL1; n = 4), 7x105 cells/kg (DL2) or 2x106 cells/kg (DL3) after 3 days of cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) lymphodepletion.

READ MORE: Liso-Cel Yields High Response Rates and Positive PROs in LBCL

Anbal-cel is a CD-19 targeted chimeric antigen receptor (CAR) T-cell therapy integrated with Curocell’s OVISTM (Overcome Immune Suppression) platform. The platform allows the cell therapy to be knocked-down for both PD-1 and TIGIT receptors.

Overall, Kim and colleagues that 9 patients responded with a complete response (CR), for an overall response rate (ORR) and CR rate of 82%. Three patients treated in DL1 had CRs and these responses have lasted for over 12 months in 2 patients. All patients dosed in DL3 have achieved a CR.

No patients experienced dose-limiting toxicities and the maximum tolerated dose was not reached. About half of the patients (n = 5; 46%) experienced cytokine release syndrome (CRS). These cases were mostly mild (grade 1 or 2; n = 3; 27%) but 2 patients (18%) had grade 3 CRS. CRS onset took a median of 7 days (range, 1-16) and lasted a median of 5 days (range, 1-19).

One patient in DL3 experienced grade 2 immune effector cell-associated neurotoxicity syndrome which onset 7 days after infusion and lasted for 13 days. This patient had central nervous system involvement prior to the study. Other common grade 3/4 treatment-related adverse events included anemia (n = 2; 18%), neutropenia (n = 2; 18%), and thrombocytopenia (n = 2; 18%).

Investigators observed dose-dependent expansion of the cell therapy with peaks at 15.4 days in DL1, 15.8 days in DL2, and 14.5 days in DL3. Median maximal expansion and exposure during the first 28 days following infusion also proportionally increased according to dose. A phase 2 trial of anbal-cel has now commenced and patient enrollment is ongoing based on the promising phase 1 study data.

“We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology,” Kim added.2

REFERENCES
1. Kim WS, Kim SJ, Yoon SE, et al. Phase 1/2 study of anbal-cel, novel anti-CD19 CAR-t therapy with dual silencing of PD-1 and TIGIT in relapsed or refractory large B cell lymphoma. Presented at: EHA 2022 Congress, June 9-12, Vienna, Austria and virtually. Abstract #S214.
2. Curocell announced impressive CR rate in Phase 1 study with anbal-cel, the next generation CD19 CAR-T integrated OVIS™ platform. News release. Curocell. June 13, 2022. https://www.biospace.com/article/releases/curocell-announced-impressive-cr-rate-in-phase-1-study-with-anbal-cel-the-next-generation-cd19-car-t-integrated-ovis-platform/