A review of Blood highlights!

Article source: Pharmaceutical Guanlan

On June 3, Reindeer Medical and Cinda Biosciences jointly announced that the fully human BCMA CAR-T cell injection (CT103A, IBI326) jointly developed by the two companies for the treatment of relapsed/refractory multiple myeloma (R/R MM) The preliminary results of the Phase 1 clinical study were officially published in Blood, a top academic journal in the field of blood.

Public information shows that CT103A uses lentivirus as a gene vector to transfect autologous T cells.

The publication of Blood magazine is a clinical study on the treatment of R/R MM in China, which was conducted in the Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

1) In terms of effectiveness, the objective response rate (ORR) of 18 subjects was 100%, and the complete response (CR)/strictly complete response (sCR) was 72.

In addition, subjects who have previously received murine BCMA CAR-T treatment can still benefit from CT103A.

2) In terms of safety, immune effector cell-related neurotoxicity syndrome (ICANS) was not observed in all dose groups.

3) In terms of CAR-T cell expansion, digital PCR technology was used to detect, and the results showed that CAR-T cell expansion reached a peak at a median time of 12 days after reinfusion, and there was no significant difference in the PK parameters of each dose group.

4) In terms of immunogenicity, the level of anti-drug antibody (ADA) of 18 subjects was tested, and only 1 subject was observed to be positive.

Why did this research arouse the high attention of Blood magazine? The review articles of three experts Lydia Sarah, Hui Lee and Kwee L.

The first is that CT103A has an eye-catching persistence in clinical practice.

"We have seen that although the maximum concentration of circulating CT103A is lower than that reported by other CAR-T therapies, the median duration it brings to the follow-up period is 308 days, and this result may follow up later We have observed a strong expansion of T cells in all subjects.

The second is that CT103A has a relatively low binding affinity.

The third is to include subjects who have previously received murine BCMA CAR-T treatment for relapse.

Note: The original text has been deleted

Reference materials:

[1] The research results of the holistic BCMA CAR-T therapy jointly developed by Cinda Biology and Reindeer Medical have been reviewed in the “Blood” journal of the American Society of Hematology.

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