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

NCT04697940 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
  • Decitabine-primed Tandem CD19/CD20 CAR T Cells

Interventions

BIOLOGICAL

Decitabine-primed Tandem CAR19/20 engineered T cells

Phase I dose escalation (3+3) : dose 1 (0.5 × 10\^6 cells per kg) dose 2 (2 × 10\^6 cells per kg) dose 3 (5 × 10\^6 cells per kg) Phase II: Appropriate dose

DRUG

Fludarabine

Intravenous fludarabine 25-30 mg/m\^2/day on days -5, -4, and -3.

DRUG

Cyclophosphamide

Intravenous cyclophosphamide 300-500 mg/m\^2/day on days -5, -4, and -3.

Sponsors & Collaborators

  • Han weidong

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04697940 on ClinicalTrials.gov