FDA Grants Fast Track Designation to Novel CAR T-Cell Therapy for B-Cell Malignancies


The FDA granted fast track designation to the novel “switchable” CAR-T cell therapy known as CLBR001 + SWI019 for the treatment of B-cell malignancies.

The FDA has granted fast track designation to the novel “switchable” CAR-T cell therapy known as CLBR001 + SWI019, according to Calibr, the developer of the therapy.

The therapy is currently being evaluated as a treatment for B-cell malignancies. A phase 1 clinical trial of CLBR001 + SWI019 (NCT04450069) has begun enrolling subjects at multiple sites in the US to assess the safety and tolerability of the cell therapy.

The current clinical trial is enrolling patients with blood-based cancers that has recurred following remission or did not respond to initial treatments. However, the switchable CAR-T cell platform employs a universal design that has the potential to be applied to solid-tumor cancers and other types of blood cancers in the future, which may provide potential advantages in an area that CAR-T cell therapies have not yet been as successful.

According to the company, CLBR001 + SWI019 leverages patients’ own immune cells to treat cancer, putting the cells under control of a novel molecular “switch” that attempts to diminish possibly life-threatening side effects that have impeded the use of cell therapies to date.

“The versatility and potential for greater safety enabled by this switchable platform can yield significant benefits for patients and we look forward to the opportunity to accelerate its development,” Travis Young, PhD, vice president of Biologics and leader of the CAR-T program at Calibr, said in a press release.

The CAR T-cell platform incorporates the SWI019 antibody, which acts as a switch, activating the CLBR001 engineered cells and directs them to engage the cancer target. This process has the potential to allow doctors to have more control over the therapy, thereby providing a significant safety advantage.

In preclinical studies, CLBR001 + SWI019 proved highly effective at eliminating tumors while simultaneously controlling the level of cytokines produced in response to treatment. Further, by switching the CLBR001 cells “on” and “off,” Calibr suggested that the approach allows the engineered cells to “rest”, which in preclinical models offered greater efficacy.


FDA grants Fast Track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019 [news release]. La Jolla, California. Published October 1, 2020. Accessed October 1, 2020. https://www.eurekalert.org/pub_releases/2020-10/sri-fgf100120.php#:~:text=Calibr's%20switchable%20CAR%2DT%20cell,provide%20a%20significant%20safety%20advantage.

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