dm+d

Unassigned

New Medicines

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)

Information

New molecular entity
Novartis
Novartis

Development and Regulatory status

None
Phase I Clinical Trials
Phase I Clinical Trials

Category

Autologous CD19-directed CAR-T cell therapy developed using the T-Charge platform. The manufacturing process allows for in vivo expansion providing T cells with better ability to self-renew and proliferate than first-generation CAR-T cell therapies. [1,2]
The overall annual incidence of DLBCL in Europe is 3.8 per 100,000 but the incidence increases with age and varies considerably across Europe [5].
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
Intravenous infusion

Trial or other data

Dec 21Early data from multicentre PI study (NCT039608, n=20) shows promising results in pts with DLBCL who received a single treatment of YTB323 at two dose levels (either 2.5×106 CAR+ cells, DL1; n=4 or 12.5×106 CAR+ cells, DL2; n=16. Of 15 pts who received YTB323 at DL2 at > 3 months prior to the data cut-off, the complete response (CR) rate was 73% (95% CI: 44.9% to 92.2%), including 2 pts who were in CR prior to treatment with YTB323. There were no new safety signals beyond those previously known to be related to CD19-directed CAR-T cell therapy. Six pts experienced CRS including 5 of grade 1/2 and 1 of grade 4. Five pts had neurological adverse reactions of which 2 were considered serious (both at DL2; one a grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and the other a grade 2 seizure that resulted in a grade 3 ICANS). Recruitment for this trial is ongoing with the trial expected to complete in October 2025. [1-4]