Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the use of 131-I apamistamab followed by CD19-targeted CAR T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia B-ALL or diffuse large B-cell lymphoma DLBCL. This pilot trial aims to determine the maximum tolerated dose of 131-I apamistamab when given before CAR T-cell infusion and to assess the safety of a lower dose if the higher dose is not tolerated. The study is conducted by Memorial Sloan Kettering Cancer Center and is an early phase trial focused on these blood cancers. Patients will receive an infusion of 131-I apamistamab 5 to 7 days before a single infusion of CAR T-cells. The CAR T-cell dose varies by disease type 1 million CAR T-cells per kilogram for B-ALL and 2 million per kilogram for DLBCL. The 131-I apamistamab may be given as an inpatient or outpatient treatment based on investigator discretion. After the CAR T-cell infusion, patients will be monitored as inpatients for at least 7 days or longer if clinically needed. Participants will be closely observed throughout the trial with assessments including monitoring for dose-limiting toxicities and determining the maximum tolerated dose within 30 days after treatment. The study involves detailed eligibility screening, including disease status and organ function tests. Researchers will track safety and treatment effects, and participation may last until the primary outcomes are evaluated, with follow-up as clinically indicated. The study excludes patients with certain infections, cardiac conditions, or other health issues that could affect safety.

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma