CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

December 5, 2018 updated by: Shenzhen Second People's Hospital

The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035

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

12 years to 73 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:

  1. AST and ALT ≤ 3 times upper limit of normal range for age,
  2. Serum creatinine ≤ 1.6 mg/dl,
  3. Direct bilirubin ≤2.0 mg/dl,
  4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
  5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria:

  1. Active, uncontrolled infection
  2. Active hepatitis B or hepatitis C
  3. HIV Infection
  4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
  5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
  6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
  7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.

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: Experimental: CART19 cell and auto-HSCT
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
Biological: CART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
Time Frame: day 28
The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
day 28

Collaborators and Investigators

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

Sponsor

Shenzhen Second People's Hospital

Investigators

  • Principal Investigator: Weihong Chen, M.D., Ph.D., The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
  • Principal Investigator: Xin Du, M.D., Ph.D., The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
  • Principal Investigator: Xiaochun Wan, Ph.D., Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

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)

June 1, 2018

Primary Completion (Anticipated)

June 2, 2021

Study Completion (Anticipated)

September 2, 2021

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Weihong Chen06062018

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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