A combination of humanized anti-BCMA and murine anti-CD38 CAR-T cell therapy in patients with relapsed or refractory multiple myeloma

Abstract

Chimeric antigen receptor T (CAR-T) cells are a promising approach in hematopoietic malignancies. We evaluated the safety and efficacy of a combination of humanized anti-BCMA and murine anti-CD38 CAR-T cell therapy in patients with relapsed or refractory multiple myeloma (R/RMM). Twenty-two R/RMM patients, with a median age of 56 years and a median number of previous therapies of 8, were included in the study. Both CAR-T cells infusion doses were 2.0 × 10⁶/kg. The overall response rate (ORR) was 90.9%, with 12 patients (54.5%) achieving a strict complete response/complete response (sCR/CR). The 24-month overall survival (OS) rate was 56.6%, and the progression-free survival (PFS) rate was 48.7%. Cytokine release syndrome (CRS) of grades 1–2 occurred in 16 patients (72.7%) and of grade ≥3 in six patients (27.3%). Immune effector cell-associated neurotoxic syndrome (ICANS) of grades 1–2 occurred in three patients (13.6%). The combination therapy is potential in R/RMM patients.

Trial registration: The patients were enrolled in clinical trials registered as ChiCTR1800017051.

Keywords:

• Anti-BCMA CAR-T
• anti-CD38 CAR-T
• combination therapy
• safety
• efficacy

Acknowledgments

We thank patients for their participation in our experimental studies and clinical trials.

Ethical approval

This study was approved by the Medical Ethics Committee of the Department of Hematology, Tianjin First Center Hospital (Tianjin, China) (Approved No 2015002X). The patients agreed to participate in our clinical trials. They agreed to the use of their specimens and data for our study.

Author contributions

ZMF: concept and design. ZH: drafting or revision of the manuscript. LM, YT, LJY, and XX: acquisition of data. YT: analysis and interpretation of data. All authors: writing, review, and/or revision of the manuscript. ZMF: study supervision.

Disclosure statement

The authors have no conflicts of interest to report.