Zevorcabtagene Autoleucel

Overview

CT053 is a fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM).

SparkCures ID 346
Developed By CARsgen Therapeutics
Generic Name Zevorcabtagene Autoleucel
Additional Names Zevor-cel, CT053
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit

September 21, 2022

As of August 31, 2022, 17 patients with R/R MM received zevor-cel infusion in the Phase 2 portion of the clinical trial and have been followed for a median of 113 days (range: 9 to 373). Of these 17 patients, five patients (29.4%) had extramedullary disease (EMD; ≥1 plasmacytoma) and nine patients (52.9%) had high-risk cytogenetic features. Patients were heavily pretreated with a median of six prior lines of therapy (range: 4 to 17). All patients were refractory to their last line of therapy. Prior to zevor-cel infusion, patients received lymphodepletion regimen of fludarabine (30mg/m2 for three consecutive days) and cyclophosphamide (500mg/m2 for two consecutive days).

Efficacy

In the 11 evaluable patients who had at least eight weeks follow-up, including four patients with EMD, the objective response rate was 100% (very good partial response, complete response, or stringent complete response) and responses deepened for patients with longer follow-up. Since all responses are ongoing, the median progression-free survival, median overall survival and median duration of response have not been reached, and the complete response/stringent complete response rate is not mature. All patients with available MRD results at week 4 were MRD negative by next-generation of sequencing.

Safety

No death occurred and no patient experienced Grade 3 or higher cytokine release syndrome. Cytokine release syndrome was observed in 10 of 17 patients (59%), all reported as Grade 1 or 2. One transient Grade 3 immune effector cell-associated neurotoxicity syndrome event was reported and the patient fully recovered; no neurological toxicity with parkinsonian features was observed. For the management of post-infusion symptoms, five of 17 patients (29%) received tocilizumab and one patient (5.9%) received corticosteroids. Notably, three patients have received outpatient zevor-cel treatment in this study, and the two patients were admitted into the hospital for symptom management for 1 or 2 days.

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