Novartis announces the first clinical data therapy preparation time of CD19 CAR-T under the new process <2 days

SourceMedical Cube Pro

TextBailu

On December 13, Novartis shared the first human test data of CAR-T manufactured by its innovative technology for DLBCL at the annual meeting of the American Society of Hematology (ASH)

The extension of the in vitro T cell culture cycle will deplete the CAR-T final product of the original and stem cell memory T cell subsets related to the improvement of anti-tumor efficacy

Novartis’ YTB323 is an autologous CD19-targeted CAR-T cell therapy.

In YTB323, primitive/stem cell memory T cells (CD45RO–/CCR7+) are retained

YTB323 has the same CAR transgene as Kymriah

Patients received a single dose of YTB323 at 3 different dose levels

As of April 16, 2021, 15 cases of relapsed/refractory (r/r) DLBCL were treated with YTB323: 4 cases with DL1 level, 10 with DL2 level, and 1 case with DL3 level

In terms of safety, among the 15 evaluable patients, 4 cases (27%) were reported with at least one grade 3 adverse event (AE), 6 cases (40%) were reported with at least one grade 4 AE, and 2 cases ( 13%) At least one grade 5 AE

In terms of effectiveness, at the DL1 level, the efficacy of 4 patients can be evaluated at the third month, and the ORR and CR rates are both 25% (95%CI, 0.

Source: ASH official website

In general, at the DL2 level, YTB323 shows good efficacy and safety

In addition, Novartis also used the preparation process in the BCMA-targeted CAR-T therapy (PHE885), which is used for multiple myeloma (MM), which is also the target area of ​​Johnson & Johnson and Bristol-Myers Squibb

Johnson & Johnson has set a high-efficiency standard in the field of BCMA targeted CAR-T, but Dr.

Of course, it is still too early to discuss the durability of these two drug candidates, but because the early data is consistent with Novartis’s expectations for T-Charge, the team has already embarked on more rigorous testing

Reference materials:

1# 740 A First-in-Human Study ofYTB323, a Novel, Autologous CD19-Directed CAR-T Cell Therapy Manufactured Usingthe Novel T-ChargeTM platform, for the Treatment of Patients (Pts) withRelapsed/Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL) (Source: ASH official website)

2# 2848 Preservation of T-CellStemness with a Novel Expansionless CAR-T Manufacturing Process, Which ReducesManufacturing Time to Less Than Two Days, Drives Enhanced CAR-T Cell Efficacy (Source: ASH official website)