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drugset / Trial / NCT04697940

Decitabine-primed Tandem CD19/CD20 CAR T Cells Treatment in r/r B-NHL

NCT04697940 ↗

Phase 1/2 Active not recruiting 33 enrolled Han weidong
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, phase 1/2 study has the primary objective of decitabine-primed tandem CART 19/20 in patients with B-NHL who were confirmed as r/r B cell Non-Hodgkin's Lymphoma. A total of 19 to 33 patients are planned to be enrolled and receive decitabine-primed tandem CART 19/20 cell infusion. Phase 1 (9 to 18 cases) is dose escalation part, and phase 2 (10 to 15 cases) is expansion cohort part.

Timeline

Start
2021-04-15
Primary completion
2025-05-31
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine-primed Tandem CAR19/20 engineered T cells Cell therapy 0.5 cells/kg Other
Subject Decitabine-primed Tandem CAR19/20 engineered T cells Cell therapy 2 cells/kg Other
Subject Decitabine-primed Tandem CAR19/20 engineered T cells Cell therapy 5 cells/kg Other
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

B-cell non-Hodgkin lymphoma