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Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

NCT04626726 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-13

No results posted yet for this study

Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Conditions

  • Adult B Acute Lymphoblastic Leukemia

Interventions

DRUG

CD19 CAR-T

CD19 CAR-T infusion for patients with CD19 positive tumor cells

DRUG

CD22 CAR-T

CD22 CAR-T infusion for patients with CD22 positive tumor cells

DRUG

CD19+CD22 CAR-T

CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells

DRUG

Fludarabine

25mg/㎡ for D-4、D-3 and D-2

DRUG

Cyclophosphamide

500mg/㎡ for D-3 and D-2

Sponsors & Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianmin Luo, PhD&MD · The Second Hospital of Hebei Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-05-30
Completion
2023-05-30

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 NCT04626726 on ClinicalTrials.gov