drugset / Trial / NCT04553393

Decitabine-primed Tandem CD19/CD20 CAR T Cells Plus Epigenetic Agents in Aggressive r/r B-NHL With Huge Tumor Burden

NCT04553393

Phase 1/2 Unknown 80 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label, multi-cohorts, phase 1/2 study has the primary objective of comparing decitabine-primed tandem CART 19/20 solo, with decitabine-primed tandem CART 19/20 plus chidamide, decitabine-primed tandem CART 19/20 plus decitabine, and decitabine-primed tandem CART 19/20 plus decitabine+chidamide in patients with aggressive B-NHL who were confirmed as Relapsed and/or Refractory B cell Non-Hodgkin's Lymphoma with hugh tumor burden (Sum of the Product of the perpendicular Diameters for multiple lesions, SPD ≥ 100cm\^2 or the largest-diameter of tumor ≥ 10 cm.).

Timeline

Start
2020-09-09
Primary completion
2021-09-08
Completion
2022-09-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule
Subject Decitabine-primed Tandem CAR19/20 engineered T cells Cell therapy
Subject Tucidinostat Small molecule Oral