Renal Cell Carcinoma CAR T-Cell Therapy Fast Tracked

The FDA has granted fast track designation to Allogene Therapeutics’ chimeric antigen receptor (CAR) T-cell therapy ALLO-316 for the potential treatment of advanced or metastatic clear cell renal cell carcinoma (RCC).¹

“Metastatic solid tumors have historically been a challenge to treat regardless of treatment modality, creating a large unmet need for patients and a necessity for scientific innovation,” Rafael Amado, MD, executive vice president, research and development, and chief medical officer, Allogene, said in a statement.¹

ALLO-316 is currently being evaluated in the phase 1, dose-escalation TRAVERSE trial (NCT04696731). The study is currently recruiting a target enrollment of 120 participants. The study follows a 3+3 design and patients are treated with the cell therapy after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and the company’s ALLO-647 lymphodepletion agent.

The goal of the study is to determine a recommended phase 2 dose. Primary outcomes include dose-limiting toxicities resulting from ALLO-316 treatment alone as well as in combination with ALLO-647.

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ALLO-316 is a CD70-targeted CAR T-cell therapy. CD70 is highly expressed in RCC and selectively expressed in other cancers. Allogene is also assessing the candidate in preclinical studies for other cancers.

“We have our sights set on confronting solid tumors where the need is unquestionably high. We remain optimistic for the potential of our AlloCAR T platform to address the challenge and we look forward to generating data from our ongoing Phase 1 trial,” Amado added.¹

Allogene’s allogeneic cell therapies are developed using their AlloCAR T platform. All trials assessing AlloCAR T candidates were previously placed on clinical hold in October 2021 after 1 patient treated with ALLO-501A in the phase 1/2 ALPHA-2 study (NCT04416984) exhibited a chromosomal abnormality. The hold was removed in January 2022 after it was determined that the abnormality was unrelated to Allogene’s gene-edited therapies.² The phase 2 part of the ALPHA-2 study is expected to initiate in mid-2022.

“Allogeneic CAR T therapy is a rapidly developing field that continues to evolve both in scope and impact, and the findings from our investigation will help advance innovation in the fields of gene editing and cell and gene therapy. As the leading developer of allogeneic cell products, we look forward to resuming our clinical trials as we work to fulfill our commitment to bring patients the first allogeneic CAR T product,” Amado said in an earlier statement.²

REFERENCES

1. Allogene Therapeutics receives FDA fast track designation for its first solid tumor candidate, ALLO-316 in the treatment of renal cell carcinoma. News release. March 10, 2022. https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-receives-fda-fast-track-designation-its
2. Allogene Therapeutics announces removal of FDA clinical hold across all AlloCAR T™ clinical trials. News release. January 10, 2022. https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-announces-removal-fda-clinical-hold-across