CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

October 19, 2017 updated by: Henan Cancer Hospital

A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia

The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T.

Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • 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
    • Henan
      • Luoyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • 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

2 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. 2 years to 70 years, expected survival > 3 months;
  • 2. CD19 positive B-cell acute lymphoblastic leukemia;
  • 3. ECOG < 2；
  • 4. The tumor load in the bone marrow is less than 60%;
  • 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
  • 6. No leukemia cells in the central nervous system;
  • 7. No serious allergic constitution;
  • 8. No other serous diseases that conflicts with the clinical program;
  • 9. No other cancer history;
  • 10. No serious mental disorder;
  • 11. female participants of reproductive potential must have a negative serum pregnancy test;
  • 12. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  • 1. Pregnant or lactating women;
  • 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  • 3. Active hepatitis B or hepatitis C infection;
  • 4. Recent or current use of glucocorticoid or other immunosuppressor;
  • 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
  • 6. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD19 CAR-T
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
Drug: Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).
Drug: Fludarabine
Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).
Biological: CD19 CAR-T
CD19 CAR-T cells will be administered after completion of the chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety as assessed by the occurence of study related adverse events
Time Frame: 30 days
number of participants with adverse events
30 days
anti-tumor responses of CD19 CAR-T cells
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of the CD19 CAR+ T cells
Time Frame: 1 year
determine duration of in vivo survival of CD19 CAR-T cells
1 year
Number of participants who have T cells ablated with cetuximab
Time Frame: 1 year
The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.
1 year

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Collaborators

The Pregene (ShenZhen) Biotechnology Company, Ltd.

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)

August 16, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH152

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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