December 1, 2022

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CYAD-101: World First non-gene editing allogeneic CART Phase I results

CYAD-101: World First non-gene editing allogeneic CART Phase I results


CYAD-101: World First non-gene editing allogeneic CART Phase I results. Celyad announced the results of the first phase of CYAD-101 clinical trial at the ASCO-GI conference in 2021.

On January 18, 2021, a Belgian biopharmaceutical company, Celyad Oncology, announced on its official website the world’s first phase one clinical trial of non-gene coding allogeneic CART cells (CYAD-101) combined with FOLFOX chemotherapy in the treatment of refractory metastatic colon cancer As a result, this is a non-genetically encoded CART drug candidate based on the natural receptor NKG2D and TCR inhibitor (TIM).

 CYAD-101: World First non-gene editing allogeneic CART Phase I results 

CYAD-101 CAR structure

There are 15 patients with refractory and unresectable mCRC in the first phase of CYAD-101, all of whom are relapsed or refractory patients who have progressed after receiving oxaliplatin or irinotecan for chemotherapy. The first phase of CYAD-101 clinically chooses the method of dose escalation for evaluation, each injection of 1×108, 3×108, 1×109 cells, and pretreatment with FOLFOX.

CYAD-101: World First non-gene editing allogeneic CART Phase I results

CYAD-101 combined with FOLFOX treatment plan

 

Clinical outcome

The latest results show that the median overall survival time of patients is 10.6 months, and the median progression-free survival time is 3.9 months;

8 out of 15 patients had reduced tumor burden, and 6 out of 9 patients were at level 3 dose (1×109);

According to the RECIST 1.1 standard, there were 2 patients with partial remission (PR), including 1 patient with KRAS mutation;

Another 9 patients had stable disease (SD), including 7 patients with stable disease lasting more than 3 months;

Among the 4 patients who received level 3 doses and could participate in the analysis of peripheral blood, new T cell clones in peripheral blood were observed in 3 patients, indicating that endogenous immune regulation may be important for regulating CYAD-101 in the treatment of mCRC mechanism.

In addition, after receiving the first two CYAD-101, the patients who showed partial remission observed cytokine regulation.

During the treatment, no treatment-related adverse events of grade 3 or higher were observed, and they were well tolerated. At the same time, no clinical response of graft versus host reaction (GvHD) was observed.

CYAD-101: World First non-gene editing allogeneic CART Phase I results

Luminex profile

The latest data were published in the 2021 Gastrointestinal Cancer Symposium ASCO-GI of the American Society of Clinical Oncology.

The preliminary data of the expanded cohort of CYAD-101 combined with FOLFIRI chemotherapy will be announced in the first half of 2021. The phase 1b clinical trial of combining with Merck’s PD-1 antibody KEYTRUDA® in the treatment of refractory microsatellite stable/mismatch repair intact mCRC will be It will be launched in the first half of 2021.

(source:chinannet, reference only)


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