Nohla Therapeutics initiates Phase 2 LAUNCH clinical trial to assess optimal dosage of innovative cell therapy for those with acute myeloid leukemia.
A treatment made from umbilical cord blood is helping oncology and hematology specialists at Norton Cancer Institute reduce infections in patients getting high-dose chemotherapy to treat acute myeloid leukemia (AML).
The intensive chemotherapy needed to treat AML commonly triggers infections that can become life-threatening.
To help solve this problem, Norton Cancer Institute is taking part in a clinical trial announced earlier this year by Nohla Therapeutics, Inc. The Phase 2 LAUNCH trial is evaluating Nohla’s lead product candidate, dilanubicel (NLA101), in adult patients with AML who are at risk for chemotherapy-related infection. This is an open-label, multi-center, controlled, dose-finding clinical trial.
The LAUNCH trial will enroll approximately 220 adult patients in order to evaluate dilanubicel’s ability to reduce the rate of high-risk infections. The study will strive to identify the product’s lowest effective cell dose.
Dilanubicel was developed to provide short-term, temporary bone marrow function until a patient’s immune system recovers, with no need for complex HLA protein matching. Over 150 infusions of the product have been administered across six clinical trials since 2006. This therapy has shown potential to overcome the broad safety and logistical risks of patient-specific cell therapies that are customized for individual patients.
According to Joseph J. Maly, M.D., principal investigator for the study and hematologist/oncologist with Norton Cancer Institute, options for treating AML have improved in recent years, yet patients still can face significant complications.
“Our aim is to avoid infections that can lead to longer hospitalizations and delays in care for our patients,” Dr. Maly said.
Additional information about the LAUNCH trial (NCT03301597) can be found at ClinicalTrials.gov.