NT-I7 + CAR T-cell Therapy for Non-Hodgkin's Lymphoma

This trial explores whether adding NT-I7 (Efineptakin Alfa), a long-acting IL-7 protein that aids T-cell growth, can enhance the effectiveness of CAR T-cell therapy for individuals with relapsed or stubborn large B-cell lymphoma. CAR T-cell therapy modifies a patient’s T-cells to better target cancer cells. Researchers aim for NT-I7 to extend the lifespan and improve the function of these T-cells, potentially increasing the likelihood of reducing the cancer. This trial may suit those diagnosed with certain types of non-Hodgkin's lymphoma that have not responded well to previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

The trial requires that you stop taking chemotherapy, biologic, or hormonal therapy for cancer treatment at least 14 days before the first NT-I7 injection. However, you can continue using hormones for non-cancer-related conditions like insulin for diabetes.

Research has shown that NT-I7, when combined with CAR T-cell therapy, is generally safe for patients with relapsed diffuse large B-cell lymphoma (DLBCL). One study found that 81.1% of patients experienced tumor shrinkage or disappearance, indicating a strong response to the treatment. Importantly, the side effects were mostly mild and manageable.

Another study found that higher doses of NT-I7 led to positive responses in all patients, with side effects remaining manageable.

Researchers are excited about NT-I7 combined with CAR T-cell therapy for treating Non-Hodgkin's Lymphoma because it offers a unique approach by enhancing the immune response. Unlike standard treatments like chemotherapy and radiation, which can be harsh on the body, NT-I7 is designed to boost the body's own immune cells, specifically T-cells, making the therapy potentially more effective and less toxic. This treatment is administered through intramuscular injections, which could be more straightforward and less invasive than traditional intravenous methods. By potentially amplifying the effects of CAR T-cell therapy, NT-I7 represents a promising advancement in making cancer treatments more effective and targeted.

This trial studies NT-I7 in combination with CAR T-cell therapy to potentially enhance treatment outcomes for patients with relapsed diffuse large B-cell lymphoma (DLBCL). Research has shown that NT-I7, when combined with CAR T-cell therapy, achieves an 81.1% success rate in shrinking cancer in DLBCL patients. NT-I7 is a long-lasting form of a natural protein called IL-7, which increases T-cells, crucial for fighting cancer. Studies suggest it can enhance CAR T-cell therapy by growing and maintaining these cells. This combination may lead to better tumor responses and improved outcomes.¹³⁴⁶⁷