Metastatic renal cell carcinoma (RCC) is an advanced kidney cancer with limited treatment options and a five‑year survival rate below 17%.

With CIRM’s support, Allogene Therapeutics is developing ALLO‑316, an allogeneic CAR‑T cell therapy that targets CD70, a protein highly expressed on clear cell renal cell carcinoma (ccRCC) tumors. The approach builds on the success of CAR‑T therapies in blood cancers.

The FDA recently granted ALLO‑316 a Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring its potential to address a critical unmet need. Early Phase 1 TRAVERSE trial results show encouraging response rates and deeper anti‑tumor activity, marking a meaningful step forward.

CIRM spoke with John LeGall, MD, the principal investigator for ALLO‑316 and a pediatric hematologist/oncologist, about the therapy’s development and the importance of advancing this research.

Can you provide an overview of your research?

Metastatic renal cell carcinoma (RCC) is an advanced kidney cancer with few treatment options and a five‑year survival rate below 17%.

With CIRM’s support, Allogene Therapeutics is developing ALLO‑316, an allogeneic CAR‑T cell therapy that targets CD70, a protein highly expressed on clear cell renal cell carcinoma (ccRCC) tumors. The approach builds on the success of CAR‑T therapies in blood cancers.

The FDA recently granted ALLO‑316 a Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring its potential to meet a critical unmet need. Early Phase 1 TRAVERSE trial results show promising response rates and deeper anti‑tumor activity, marking an important step forward.

CIRM spoke with John LeGall, MD, the principal investigator for ALLO‑316 and a pediatric hematologist/oncologist, about the therapy’s development and why advancing this research matters.

How would you explain your research to someone who isn’t a scientist?

Dr. LeGall: We are developing a drug to treat cancerous tumors, including advanced kidney cancer. Unlike conventional drugs, our therapy is a “living drug.” We take white blood cells from a healthy donor and engineer them to target CD70, a protein found on kidney cancer cells. After manufacturing, the final product becomes an allogeneic CD70 CAR T engineered to find and kill these cancer cells. The CAR T cells can also multiply in the body, helping eliminate cancer throughout the system, much like natural white blood cells fight infection.

This research is exciting because a therapy like this may unlock long‑term cancer control for patients with solid tumors after a single treatment. This trial will evaluate the allogeneic CD70 CAR T therapy in patients with advanced kidney cancer to identify who is most likely to benefit.

What is the most exciting or significant finding so far?

Dr. LeGall: Many patients have had tumor lesions disappear after receiving a single treatment with allogeneic CD70 CAR T cells.

Can you share a defining moment in your life that led you to pursue this research?

Dr. LeGall: I committed to cell therapy because I wanted to develop treatments that could cure patients who were out of options. I saw many patients and families struggle with relapsed hematologic and solid tumors, and that experience pushed me to pursue new therapies with curative potential. One patient, a firefighter and mixed‑martial‑arts fighter, was recently married when his leukemia returned. He was solemn but tough and determined to try one last shot at remission. I cared for him as he underwent an investigational CAR‑T therapy—the only option left. The treatment likely extended his life by six months. It wasn’t the cure we hoped for, but he and his family deeply appreciated our efforts.

Have there been any unexpected moments of joy or frustration during the research process?

Dr. LeGall: When a patient, who otherwise has no options for treatment, has the courage to sign up to try a new therapy in their fight against cancer, I always find myself incredibly inspired. When that patient manages to substantially extend their life or “feel good” for the first time in years, there is joy and elation knowing that years of work is making a meaningful difference for patients. The team at Allogene is focused on trying to achieve that joy as often as possible.

What is one key message you want to tell the public about your research?

Dr. LeGall: Engineering the immune system to directly fight cancer with CAR T cells has been curative in hematologic (blood) cancers, and we hope to deliver on that promise to patients with solid tumors like advanced kidney cancer. 

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To learn more about Allogene’s recent RMAT designation, read here.