A phase 1 trial will investigate the repeated administration of a novel CAR-T cell therapy, B4t2-001, via the PrismCore platform in patients with solid tumors, according to Bio4t2, the manufacturer of the drug.
CAR-T cell therapies, which have shown landmark success in the treatment of blood cancers in recent years, work by extracting and reengineering immune cells (T cells) to target certain proteins found on cancer cells. In this case, the T cells are being trained to recognize and attack BT-001, an antigen found on solid tumors. The T cells are then multiplied and infused back into the patient.
Researchers are analyzing whether B4t2-001 can be given without preparatory chemotherapy — known as lymphodepletion — which is usually done prior to the administration of CAR-T cell products. The main goals of the trial are safety, tolerability, observing how the drug moves throughout and works within the body and preliminary efficacy (anti-tumor effects).
To participate, patients must have BT-001—positive solid cancers; be able to perform all of their daily tasks with little to no help; have tumors that are 4cm or small; have sufficient bone marrow, liver, kidney and lung function; and agree to use contraception, if they are within childbearing age, according to the trial’s listing on ClinicalTrials.gov.
“PrismCore identifies targets on invasive cancers and Bio-Engine harnesses normal blood cells to create a niche for CAR-T engraftment without the use of preparative chemotherapy,” Farzad Haerizadeh, chief scientific officer, and co-founder at Bio4t2 said in a company-issued press release. “Based on the success of our pilot clinical study, Bio4t2’s CAR-T is predicted to attack the tumor again and again without the cost, complexity and toxicities, associated with lymphodepletion.”
A pilot trial of B4t-001 conducted in China showed that engraftment rates, meaning how the engineered cells establish themselves and become active in the body, was approximately 40% to 50%, even without prior lymphodepletion.
While CAR-T cell therapies are most commonly used to treat patients with blood cancers, this is not the first study to investigate this treatment modality in solid tumors. For example, findings published last year showed that the investigational CAR-T cell therapy, BNT211-01, was promising in treating patients with CLDN6-positive relapsed or refractory solid cancers. Study data showed that among 21 patients evaluated, one-third responded to the therapy, with one patient experiencing a complete response, meaning that their cancer completely disappeared from treatment. Additionally, researchers reported a 67% disease control rate.
“This new phase 1 trial builds off our pilot clinical study which concluded a few weeks ago,” said Dr. Laurence Cooper, Executive Chairman of the board. “Treating solid tumors depends on identifying targets that are uniformly expressed across cancer cells and engrafting CAR-T without immunological exhaustion. We combine our PrismCore and Bio-Engine technologies to achieve both goals and advance our cutting-edge CAR-T for the many patients with solid tumors.”
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