NCT04553393

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

Treatment of Decitabine-primed Tandem Targeting CD19 and CD20 Chimeric Antigen Receptor T Cells Plus Epigenetic Agents in Aggressive Relapsed and/or Refractory Non-Hodgkin's Lymphoma Patients With Huge Tumor Burden

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.).

Conditions

• Refractory or Relapsed Aggressive r/r B-NHL With Huge Tumor Burden

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide will be added 1 month after responding to CART cells infusion
DRUG	Decitabine	Decitabine will be added 1 month after responding to CART cells infusion
DRUG	Chidamide and Decitabine	Both chidamide and decitabine will be added 1 month after responding to CART cells infusion
BIOLOGICAL	Decitabine-primed Tandem CAR19/20 engineered T cells	Tandem CAR19/20 engineered T cells

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-09-08
• Completion: 2022-09-08
• First posted: 2020-09-17
• Last updated: 2020-12-04

Locations

1 site across 1 country: China