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

The “switchable” chimeric antigen receptor (CAR) T-cell therapy CLBR001 plus SWI019 received a Fast Track designation for patients with B-cell malignancies such as non-Hodgkins lymphoma and chronic lymphocytic leukemia, according to a press release from Scripps Research.

Now that the drug development and review process has been accelerated, patients are starting to be enrolled in a phase 1 trial of the novel CAR T agent (NCT04450069). The study will assess the safety and tolerability profile of CLBR001 + SWI019 at multiple sites in the United States.

“This important designation will enable Calibr to interact with the agency on study-related items, such as appropriate data collection and study design to support the approval of this innovative therapy,” Pamela Garzone, PhD, chief medical officer of Calibr, the clinical study lead of the therapy, and primary author of the Fast Track application, said in a press release.

For this treatment, the antibody SWI019 is used as a switch by activating the engineered CLBR001 cells and directing them to engage with the patient’s disease. Physicians may have more control over the therapy, and if so, could provide significant safety advantages for patients. The investigational treatment uses the patient’s immune cells to treat their cancer and puts the cells under control of SWI019 to potentially diminish adverse effects seen with CAR T-cell therapy.

Preclinical trials have shown that this approach is highly effective at controlling the level of cytokines produced in response to therapy while it eliminates the tumor. These trials have also seen greater efficacy because this approach allows the CLBR001 cells to “rest” by turning them “on” and “off.”

“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, Calibr’s vice president of biologics and leader of its CAR-T program, said in a statement.

In the phase 1 trial, patients are being enrolled if they have blood-based cancers which have progressed after remission or did not respond to first-line treatment. This switchable CAR T-cell therapy can also be applied to solid tumors and blood cancer that are not B-cell malignancies in the future. The universal design may allow give this regimen an advantage over other CAR T-cell therapies that have not succeeded in these different settings.

By granting a Fast Track designation, Calibr, a division of Scripps Research, will be able to work closer with the FDA to develop CLBR001 + SWI019 for patients.

_Reference:

_{FDA grants Fast Track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019. News release. Scripps Research. Published October 1, 2020. Accessed October 2, 2020. https://bit.ly/3ipArEP}