This early-stage clinical study, presented at the 17th International Myeloma Workshop, exhibited the safety and efficacy of CT103A in heavily pretreated R/R multiple myeloma (RRMM) patients.
In this single-center study and single-arm trial of CT103A patients with RRMM patients, called ChiCTR1800018137, the study’s primary outcome is characterizing the safety and tolerability in patients with R/R MM. The secondary outcome of this study is the evaluation of anti-myeloma activity, cytokines, CAR-T cell persistence, and pharmacokinetics. The researchers administered 12 patients with CT103A in a 3+3 dose escalation trial after a conditioning chemotherapy regimen of cyclophosphamide and fludarabine between September 21, 2018, and June 18, 2019. The study subjects all received an average of 4 prior lines (range 3 – 6) of MM therapy.
The results showed that after data analysis, the overall response rate was 100%, and 4/12 patients achieved clinical response (CR) within two weeks post-infusion. Moreover, the sCR was 64%, and VGPR was 36% for 11 evaluable patients. The results furthered showed that four patients who have participated in a prior CAR-T trial, three have achieved sCR, and one achieved VGPR. The average amount of time the drug was present at maximum concentration was 14 days (ranging from 9 to 25) after infusion, which suggests rapid expansion of the CT103A. Also, CT103A persisted in 10/11 patients and the longest CART persistence time has reached a duration of 260 days.
The authors encouragingly wrote in their conclusion that “highly active (ORR 100%) and rapid response within two weeks, suggests CT103A could be developed as a competitive therapeutic to treat patients with RRMM.”
Li, Chunrui, et al. Clinical Responses and Pharmacokinetics of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma. Presented at the 17th International Myeloma Workshop; September 12-15, 2019; Boston, MA.
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