MedTrace Logo

Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

NCT05744037 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-24

No results posted yet for this study

Summary

To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.

Conditions

  • B-cell Non Hodgkin Lymphoma

Interventions

BIOLOGICAL

regimen with BTK inhibitor +Anti-CD19 CAR T cells

After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05744037 on ClinicalTrials.gov