1 patient died:  Clinical trial of CD33-targeted CAR-T cell therapy was suspended

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1 patient died:  Clinical trial of CD33-targeted CAR-T cell therapy was suspended

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1 patient died:  Clinical trial of CD33-targeted CAR-T cell therapy was suspended.

Recently, a patient with acute myeloid leukemia (AML) died in an early clinical trial of 2seventy ‘s CD33-targeted CAR-T cell therapy, and researchers immediately suspended the clinical study.

2seventy is an oncology spin-off company of bluebird bio , which is committed to addressing the safety of CAR-T cell therapy in the treatment of AML.

It is well known that a variety of antigens are expressed on the surface of cancer cells, but these antigens may also be present in healthy myeloid and progenitor cells. Therefore, how to treat AML with lower side effects is a problem.

In 2seventy’s view, the answer to this problem lies in modifying the CAR structure and using rapamycin as a switch for CAR-T.

Only in the presence of rapamycin, CAR-T cells will be activated, otherwise , CAR-T cells are not activated, allowing recovery of hematopoietic cells and reducing potential side effects.

On the basis of this theory, 2seventy started clinical trials last year, and they injected this new CAR-T cell, SC-DARIC33, into acute myeloid leukemia (AML) patients for the first time at Seattle Children’s Hospital.

Early signs look good, and the company reported last month that the first three patients treated were generally well tolerated after the first infusion, with no patients experiencing dose-limiting toxicities.

However, the death of the first patient who received a second infusion raised doubts about the CAR-T cell therapy.

At present, 2seventy has not announced the specific circumstances of the patient’s death.

The root cause of this serious adverse event and whether it is related to the treatment itself is still under investigation.

Seattle Children’s Hospital, where the patient was treated, suspended the study and reported the death to the FDA. Dr. Steve Bernstein , chief medical officer of 2seventy , said that the company is currently communicating with the FDA, while reviewing the experimental data and the next step of the study.

A major setback for SC-DARIC33 will allow 2seventy to focus on its non-Hodgkin lymphoma cell therapy bbT369 and its collaboration with BMS.

The details of the patient death could affect 2seventy’s broader strategy.

This suspended clinical trial is the first time that 2seventy has tested its drug-regulated CAR-T cell platform on humans.

It hopes to use this research to lay the foundation for future CAR-T research on CD33 targets and solid tumor targets.

References :
https://ir.2seventybio.com/news-releases/news-release-details/2seventy-bio-announces-clinical-study-pause-plat-08-trial-sc

1 patient died:  Clinical trial of CD33-targeted CAR-T cell therapy was suspended

(source:internetOEG5t9R5ELicH8-F76AeDg, reference only)

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