KLN-1010 multiple myeloma clinical trial begins dosing patients in US
A Phase 1 clinical trial testing the experimental therapy KLN-1010 in people with relapsed or refractory multiple myeloma has begun treating patients in the U.S.The study, dubbed inMMyCAR (NCT07075185), was already ongoing at sites in Australia, and a few months ago, U.S. regulators gave the go-ahead to expand to sites in the U.S.Now, the first U.S. patient has been dosed at Winship Cancer Institute of Emory University in Georgia.
“We are proud that Winship was selected as a leading site for this important clinical trial and that our team was able to move quickly to bring this opportunity to patients,” Sagar Lonial, MD, Winship’s chief medical officer, said in a news story from the institute.
Trial Structure and Expectations
The inMMyCAR trial is expected to enroll approximately 70 people with relapsed or refractory multiple myeloma who have already undergone at least three prior lines of treatment, including an immunomodulatory medication, a proteasome inhibitor, and an anti-CD38 antibody.Participants in the study will receive a single infusion of KLN-1010.
The study’s main goals are to evaluate the safety and tolerability of the experimental therapy and to establish a recommended dose for a future Phase 2 trial.Participants will be followed long term for up to 15 years.Recruitment is ongoing at several sites across the U.S. and Australia.
Understanding Myeloma and CAR T-Cell Therapies
Myeloma is marked by the uncontrolled growth of immune cells called plasma cells.There is a wide range of myeloma treatments currently available; one recently developed class of treatments is called CAR T-cell therapies.T-cells are immune cells that can kill cancer cells.
With CAR T-cell therapy, T-cells are engineered to carry a lab-made receptor called a CAR (chimeric antigen receptor), which directs the T-cells to attack cancer cells.Available CAR T-cell therapies work by collecting T-cells from a patient, taking them to a lab for engineering, and then infusing them back into the patient, usually after a round of lymphodepletion, a type of chemotherapy used to reduce existing immune cells and make room for the modified cells.Although this type of treatment can be highly effective, this process is time-consuming and expensive.
