MedTrace Logo

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

NCT03110640 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-27

No results posted yet for this study

Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Conditions

  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Chronic Lymphocytic Leukemia
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Hematopoietic/Lymphoid Cancer
  • Refractory Chronic Lymphocytic Leukemia

Interventions

BIOLOGICAL

anti-CD19 CAR-T

Ex vivo-expanded autologous T cells modified to express CD19 CAR

DRUG

Fludarabine

Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.

DRUG

Cyclophosphamide

Patients were given cyclophosphamide 500mg/m2/day on day -4.

Sponsors & Collaborators

  • Hrain Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Kang Yu, M.D. · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2020-06-30
Completion
2021-09-30

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 NCT03110640 on ClinicalTrials.gov