U.S., July 16 -- ClinicalTrials.gov registry received information related to the study (NCT07066397) titled 'A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL' on July 04.
Brief Summary: This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Study Start Date: July 05
Study Type: INTERVENTIONAL
Condition:
Acute Lymphobkastic Leukemia
Intervention:
BIOLOGICAL: ARM011
ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process
DRUG: Fludarabine
Administered prior to infusion of ARM011
DRUG: Cyclophosphamide
Administered prior to inf...