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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

February 2, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
B-ALLDLBCLB ALLDlbcl-CiDLBCL UnclassifiableDLBCL, Nos Genetic SubtypesDLBCL Activated B-Cell TypeDLBCL Germinal Center B-Cell TypeDiffuse Large B-cell LymphomaHGBLHGBL, Nos
Interventions
DRUG

131-I Apamistamab

Patients will receive 131-I apamistamab 5-7 days prior to a single infusion of 1x10\^6 19-28z CAR T-cells/kg for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL. 131-I apamistamab may be administered inpatient or outpatient at the discretion and judgment of the treating investigators.

BIOLOGICAL

CAR T-cell

19-28z CAR T-cells will be administered inpatient as a single infusion of 1x10\^6 19-28z CAR T-cells/kg, for those in the B-ALL cohort, or 2x10\^6 19-28z CAR T-cells/kg, for those in the DLBCL cohort. Patients will be observed inpatient for a minimum of 7 days (longer as clinically indicated and at the discretion of the treating physician).

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER