Introduction: Several BCMA CAR T-cell products have been approved for relapsed or refractory multiple myeloma (RRMM), but long-term response has not been established. There is growing interest in the use of next-generation CAR T-cell therapy in RRMM. CBG002 is an armored BCMA CAR T-cell ...
Clinical trial eligibility and exclusion criteria Inclusion criteria (1) Disease status (i) Dose-escalation phase and DIPG expansion cohort: tissue diagnosis of H3K27M-mutated DIPG with radiographically evident tumour restricted to the brainstem, or (ii) Dose-escalation phase and spinal DMG exp...
Chimeric antigen receptor (CAR) T cells targeting CD19 or CD22 have shown remarkable activity in B cell acute lymphoblastic leukemia (B-ALL). The major cause of treatment failure is antigen downregulation or loss. Dual antigen targeting could potentially prevent this, but the clinical safety...
Caron A. Jacobson, MD, instructor in medicine, Department of Medical Oncology, Dana-Farber Cancer Institute, and first author of the study presented at ASH, said that in a real-world setting, eligibility criteria and patient management factors may be very distinct from a clinical trial setting....
Now, one could argue that this is because it was a highly selected group of patients because of the clinical trial eligibility, but it also brings up the question that can we reset the disease to some extent by making those myeloma cells down to that MRD negative stage before it grows ...
1.Clinicalmonitoring30 2.Toxicitygrading31 3.Dose-limitingtoxicities(DLTs),stoppingrulesandattribution31 E.CARTCellPersistenceandLongTermFollow-up32 F.AllogeneicCARTCells33 VII.REFERENCES34 ii ContainsNonbindingRecommendations ConsiderationsfortheDevelopmentofChimericAntigenReceptor (CAR)TCellProducts GuidanceforInd...
(CAR) T-cell therapy becoming this week's top trending clinical topic. Initially, the results of two phase 3 trials suggest that CAR T-cell therapy has the potential to replace chemoimmunotherapy for some patients with large B-cell lymphoma, according to Frederick L. Locke, MD, from the ...
The viral safety of all the raw and starting materials used is crucial to ensure the safety of CAR-T cell products for patients, even in early phase clinical trials. Aim As raw and starting materials are crucial for the quality of GMP manufactured CAR-T cell products and, therefore, also ...
But interestingly, only half the patients in both cohorts actually met eligibility criteria for the initial ZUMA-1 cohort. This suggests that even though patients were sicker and older, had more comorbidities, and would not have been treated on the clinical trial, they did gain clinical benefit ...
Interestingly, the ORR was numerically higher in patients who did not receive bridg- ing therapy, which was also observed in a CD19-targeted CAR T cell trial for large B cell lymphoma17. The basis for this observation could be that patients who required bridging therapy could have more ...