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

NCT04553393 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-12-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Weidong Han, M.D. · Chinese PLA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553393 on ClinicalTrials.gov