drugset / Trial / NCT04553393
Decitabine-primed Tandem CD19/CD20 CAR T Cells Plus Epigenetic Agents in Aggressive r/r B-NHL With Huge Tumor Burden
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | — | — |
| Subject | Decitabine-primed Tandem CAR19/20 engineered T cells | Cell therapy | — | — |
| Subject | Tucidinostat | Small molecule | — | Oral |