|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
C-CAR039, a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD20, has shown safety and efficacy in the treatment of relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), according to an analysis presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The research was presented by Aibin Liang, MD, PhD, of Tongji University in Shanghai, China, and colleagues.
The dose range of C-CAR039 used in the analysis was 1.0 x 106 to 5.0 x 106 CAR T cells/kg. Following a conditioning regimen of cyclophosphamide and fludarabine, C-CAR039 was given to patients intravenously in 1 dose.
By January 31, 2021, a total of 28 patients reportedly received infusions, with 25 patients evaluable for analyses. Most (22 patients) had diffuse large B-cell lymphoma, while 1 patient had primary mediastinal B-cell lymphoma, 1 had follicular lymphoma, and 1 had transformed follicular lymphoma. Patients were a median age of 54 years (range, 28-71), and 76% had cancer of Ann Arbor stage III to IV. Patients had a median of 3 prior lines of therapy (range, 1-5). Bridging therapy had been given to 20% of patients.
The best overall response rate was reported to be 92%, with a complete response rate of 84%. Patients had a median time to response of 1.0 month (range, 0.9-1.2), and at a median follow-up of 5.3 months, 76% of patients continued to be in complete response. The 6-month estimated progression-free survival rate was 87.3% (95% CI, 71.2%-100.0%).
In analyses of the cellular kinetics of C-CAR039, the median time of maximal expansion was 11 days, and the median maximum concentration was 139,497 copies/mg of genomic DNA. The median area under the concentration-time curve through the first 28 days was 1,673,844 day*copies/mg genomic DNA.
Cytokine release syndrome (CRS) occurred in 96% of patients. CRS was reportedly of grade 1 or 2 in 92% of patients and grade 3 in 1 patient, and it occurred with a median time to onset of 3 days (range, 0-10). The median duration of CRS was 4 days (range, 1-25). Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients. Most patients (88%) had grade 3 or higher neutropenia.
The researchers concluded that in this analysis, C-CAR039 showed promising efficacy with favorable safety for patients with R/R B-cell NHL. Research is ongoing to evaluate patients with longer follow-up (ClinicalTrials.gov Identifiers: NCT04317885, NCT04655677, NCT04696432, NCT04693676).
Disclosure: This research was supported by Cellular Biomedicine Group, Inc. Please see the original study for a full list of disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Liang A, Zhou L, Li P, et al. Safety and efficacy of a novel anti-CD20/CD19 bi-specific CAR T-cell therapy (C-CAR039) in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL). J Clin Oncol. 2021;39:(suppl 15; abstr 2507). doi:10.1200/JCO.2021.39.15_suppl.2507