NCT05442515View on ClinicalTrials.gov

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

December 28, 2022

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2029

Conditions
B-NHLB-Non Hodgkin LymphomaAcute Lymphocytic LeukemiaAcute Lymphoblastic LeukemiaB-precursor ALLB-AllLymphoma, Non-HodgkinLeukemia, Lymphocytic, B CellB-Cell LymphomaB-Cell LeukemiaAcute Lymphoid Leukemia
Interventions
BIOLOGICAL

CD19/CD22-CAR-transduced T cells

CD19/CD22-CAR-transduced T cells on D0 after lymphodepleting preparative regimen

DRUG

cyclophosphamide

Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion.

DRUG

fludarabine

Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose).

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH