This phase I trial tests the safety, side effects, and effectiveness of using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T-lymphocytes (CTLs) for the treatment of pediatric patients with Hodgkin or non-Hodgkin lymphomas. TAA-CTLs have the ability to target cancer cells that have specific antigens on the cell surface (a type of substance that can stimulate the immune system). Infusion with TAA-specific CTLs may help activate tumor-specific immune responses in the patient, killing TAA-expressing cancer cells and inhibiting cancer cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05134740.
PRIMARY OBJECTIVE:
I. To assess the safety of administering two infusions of a fixed dose of multiTAA-specific CTLs (2 x 10^7/m^2 x 2) to pediatric lymphoma patients at a high risk for relapse.
SECONDARY OBJECTIVE:
I. To assess the efficacy of administering two infusions of a fixed dose of multiTAA-specific CTLs (2 x 10^7/m^2 x 2) to pediatric lymphoma patients at a high risk for relapse.
EXPLORATORY OBJECTIVE:
I. To assess the expansion, persistence and antigen spreading effects of administering two infusions of a fixed dose of multiTAA-specific CTLs (2 x 10^7/m^2 x 2) to pediatric lymphoma patients at a high risk for relapse.
OUTLINE:
Patients receive multiTAA-specific CTLs intravenously (IV) over 1-10 minutes on days 0 and 14. Patients may receive up to 6 additional doses, each separated by a minimum of 6 weeks.
After completion of study treatment, patients are followed up at weeks 4 and 8, months 3, 6, 9, and 12, and then once a year for up to 4 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorLauren Demet Scherer
