KLN-1010 multiple myeloma clinical trial begins dosing patients in US
Experimental in vivo CAR-T therapy is in Phase 1 testing
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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.
Winship doses first US patient
“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.
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.
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.
Therapy aims to create CAR-T cells in body
KLN-1010 is designed to be an in vivo CAR T-cell therapy, meaning it aims to create CAR T-cells directly inside the body. Rather than collecting T-cells and sending them to a lab to engineer them with a CAR, the therapy aims to deliver a CAR to T-cells already in the body, with the goal of allowing treatment to be given as a single infusion.
“Traditional CAR-T therapies have been highly effective for many patients, but they require multiple steps including cell collection, manufacturing time, and preparative chemotherapy,” said Nisha Joseph, MD, a hematologist and multiple myeloma specialist at Winship. “An in vivo approach is designed to create those therapeutic cells directly within the patient, which could make this type of treatment more accessible and more efficient in the future.”
Preliminary data from the ongoing Phase 1 study have been encouraging, with early responses reported among the first patients treated and the therapy appearing well tolerated so far, according to Winship. Researchers cautioned that KLN-1010 remains investigational and that more study is needed to determine its long-term safety and effectiveness. The study is sponsored by Kelonia Therapeutics, the company developing KLN-1010.
“This is an exciting advancement in the multiple myeloma space,” said Ajay Nooka, MD, MPH, associate director of clinical research of Winship Cancer Institute and director of the Myeloma Program at Emory University School of Medicine’s Department of Hematology and Medical Oncology. “It is important for eligible patients with relapsed myeloma to have access to promising investigational therapies, and for Winship to remain at the forefront of bringing those opportunities to patients.”
