Three new clinical trials aim to assess the safety and efficacy of a new cancer immunotherapy treatment, KTE-C19, in patients with three types of treatment-resistant blood cancers — refractory aggressive non-Hodgkin lymphoma (NHL), relapsed/refractory mantle cell lymphoma and relapsed/refractory B-precursor acute lymphoblastic leukemia.
All three trials, led by researchers at the University of California San Diego’s Moores Cancer Center in collaboration with Kite Pharma, and ongoing at three sites in California, Texas and Florida, are currently recruiting patients.
Cancer immunotherapy is one of the fastest growing therapy approaches in cancer research, relying on the boost of a patient’s own immune system to fight and hopefully annihilate cancer cells. The potential new immunotherapy treatment being tested — KTE-C19 — uses T cells, a type of immune cells, that are taken from the patient and engineered to recognize and destroy tumor cells. After extraction from the blood, researchers introduce, through gene transfer, potent receptors into the T cells that allow them to kill cancer cells. These T cells are then reintroduced into the patient’s circulation system and, ideally, travel to the tumor site and kill malignant cells. In this case, the drug is designed with chimeric antigen receptor (CAR) T cells, synthetic receptors that are delivered and linked to specialized subsets of T cells by gene transfer. Once in circulation, the T cells are intended to only target and kill cancer cells that express specific proteins, such as CD19, found on the malignant B cells involved in most lymphomas and leukemias.
The clinical trials, named ZUMA-1, ZUMA-2 and ZUMA-3, are led by principal investigator Januario E. Castro, MD, a professor of medicine at UC San Diego School of Medicine.
The ZUMA-1 trial (NCT02348216) is a multicenter Phase 1/2 study to assess the safety and efficacy of KTE-C19 in patients with refractory, aggressive NHL, a type of blood cancer that has not responded to standard therapies. The KTE-C19 treatment involves three days of chemotherapy, a weeklong hospital stay, and up to 15 years of follow-ups and monitoring of disease response and remission. The Zuma-2 clinical trial (NCT02601313) is a Phase 2 multicenter study targeting patients with relapsed/refractory mantle cell lymphoma to evaluate the efficacy of KTE-C19. The treatment regimen is similar to the one employed in the ZUMA-1 study. Finally, the ZUMA-3 trial (NCT02614066) is a Phase 1/2 multicentre study evaluating the efficacy and safety of KTE-C19 in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia, with similar timelines of chemotherapy, hospitalization and follow-up visits.
“Lymphomas and leukemias affect thousands of Americans every year and unfortunately a good number of them die as a direct consequence of the disease progression or toxicity from existing treatments. We have made great strides with some blood cancers, notably Hodgkin lymphoma, but others have proved more resistant, with patients exhausting all current standards of care,” Dr. Castro said in a press release.
More information on the trials, including on enrollment and eligibility criteria, are available through this link.