FDA Speeds Up Review of Kidney Cancer CAR-T Cell Therapy

The FDA has granted a fast track designation for CAR-T cell therapy for certain patients with kidney cancer.

The Food and Drug Administration (FDA) granted a fast track designation to ADI-270 for the treatment of patients with metastatic (cancer that has spread to other parts of the body) or advanced clear cell renal cell carcinoma (ccRCC; a type of kidney cancer), according to an announcement from Adicet Bio, the manufacturer of the novel drug.

In particular, the therapy is for patients with ccRCC who have been previously treated with an immune checkpoint inhibitor and a vascular endothelial growth factor (VEGF) inhibitor. The fast track designation is meant to speed up the development and review of drugs that fill an unmet need, according to the FDA’s website.

"We are pleased that ADI-270, our first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors, has been granted Fast Track Designation by the FDA," said Chen Schor, President and Chief Executive Officer of Adicet Bio, said in a company-issued press release. Schor also mentioned that ccRCC is the most common type of kidney cancer.

ADI-270 is an off-the-shelf CAR-T cell therapy. CAR-T cell therapies — which are popular in the treatment of certain blood cancers — work by engineering immune T cells to find and fight cancer. Traditionally, CAR-T cell therapies use a patient’s own T cells, but off-the-shelf products use the T cells of healthy donors.

While CAR-T cell therapies are only FDA-approved in the blood cancer space, ADI-270 is not the only agent of its kind being explored for patients with kidney cancer. Ongoing trials are exploring these drugs in different RCC populations.

READ MORE: CAR-T Cell Therapy Is ‘Exciting’ in Advanced Kidney Cancer

ADI-270 works by targeting CD70, a protein expressed on the cells of certain cancers, by using CD27, the natural receptor of CD70. As such, the drug helps immune cells find and fight cancer cells.

In September 2024, researchers plan to kick off a phase 1/2 clinical trial to study the efficacy and proper dosing of ADI-270 plus fludarabine and cyclophosphamide in patients with pretreated relapsed or refractory ccRCC. According to the study’s listing on clinicaltrials.gov, the trial will be divided into two parts:

• Patients in phase 1 will receive increasing doses of ADI-270. The researchers will take note of side effects that led to decreased dosing within a 28-day period. From that data, they will determine the maximum tolerable dose.
• Phase 2 will then measure the treatment-related and treatment-emergent side effects of the maximum tolerated dose established in phase 1. This portion of the study will continue for two years.

Researchers aim to enroll approximately 60 patients in the study, which is expected to be completed in June 2027.

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