This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma.
Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 105 patients (estimated)View More
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).
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.
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.
December 05, 2020
As of July 28, 2020, 20 subjects have enrolled, and 14 subjects have received CT053 infusion in the phase 1b portion of the study, including 8 subjects who received 1.5-1.8×108 CAR+ T cells while 6 subjects received 2.5-3.0×108 CAR+ T cells. The treated subjects had a median age of 59 years (range 42-73), had received a median of 6 (range 3-11) prior lines of treatment, 93% were triple refractory to a PI, IMiD, and anti-CD38 antibody, and 64% were penta-refractory. In addition, 36% of the subjects had extramedullary disease at baseline, and 64% had high-risk cytogenetics. All subjects received bridging therapy.
The most common ≥ grade 3 AE was hematological toxicity. All subjects experienced ≥ grade 3 neutropenia (100%) and leukopenia (100%), and 36% of subjects had ≥ grade 3 thrombocytopenia within 30 days of treatment. No grade 3 or higher CRS or neurotoxicity was observed. Twelve of 14 subjects (86%) experienced grade 1 or 2 CRS, including 2 subjects who experienced grade 2 CRS and 1 subject who had grade 2 neurotoxicity. CRS events had a generally predictable time to onset, occurring at a median of 2 days post infusion with a median duration of 4 days (range 1-6). Two subjects received tocilizumab, and one subject with grade 2 CRS received both tocilizumab and steroids. One subject experienced grade 2 neurotoxicity with complete resolution within 24 hours upon administration of dexamethasone.
At the data cutoff, 10 subjects were evaluable for at least two months of efficacy assessment with a median follow-up of 4.5 months (range 2-8). A 100% ORR was observed, with 2 stringent complete responses, 2 CRs, 1 very good partial response, and 5 partial responses. Of the 12 subjects with evaluable bone marrow samples, 11 were MRD-negative at the 10-5 sensitivity level. Responses were independent of baseline bone marrow BCMA expression.
September 23, 2019
CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma.
PRIME eligibility was based on clinical data from an ongoing CT053 BCMA CAR-T phase 1 study in China. The results from the trial were presented at an oral presentation on September 14, 2019 in Boston at the 17th International Myeloma Workshop. As of June 30, 2019, 21 out of 24 myeloma patients (87.5%) who received a median of 4.5 prior lines of myeloma therapy showed objective response. 19 out of 24 patients (79.2%) achieved complete response. There was no grade 3 or higher cytokine release syndrome. The duration of response data will be reported at a future date.
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