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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. 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 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 combined with FOLFOX treatment plan
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.
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)