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

November 25, 2019 updated by: Kang YU, First Affiliated Hospital of Wenzhou Medical University

A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objectives

  1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
  2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affilicated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5 Years to 70 Years, Male and female;
  • Expected survival > 12 weeks;
  • Performance score 0-2;
  • Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
  • Creatinine < 2.5 mg/dl;
  • ALT/AST < 3x normal;
  • Bilirubin < 2.0 mg/dl;
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  • Take contraceptive measures before recruit to this trial;
  • Written voluntary informed consent is given.

Exclusion Criteria:

  • Patients with symptoms of central nervous system
  • Accompanied by other malignant tumor
  • Active hepatitis B or C, HIV infection
  • Any other diseases could affect the outcome of this trial
  • Suffering severe cardiovascular or respiratory disease
  • Poorly controlled hypertension
  • A history of mental illness and poorly controlled
  • Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
  • Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  • Reaching a steady dose if receiving anticoagulant therapy before assignment
  • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Pregnant or lactating women
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CD9CAR-T transfer
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - incidence of adverse events defined as dose-limited toxicity
Time Frame: 180 days
incidence of adverse events defined as dose-limited toxicity
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complete remission rate
Time Frame: 1 year
Overall complete remission rate
1 year
Duration of remission
Time Frame: 1 year
Duration of remission
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

Second Affiliated Hospital of Nanchang University
Hrain Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Kang Yu, M.D., First affiliated hospital of Wenzhou medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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