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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685786
Recruitment Status : Unknown
Verified December 2018 by Shenzhen Second People's Hospital.
Recruitment status was:  Recruiting
First Posted : September 26, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Shenzhen Second People's Hospital

Study Description
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Brief Summary:
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Acute, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Biological: CART19 cell and auto-HSCT Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2, 2021
Estimated Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685786


Contacts
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Contact: Weihong Chen, M.D., Ph.D. 0086-755-83366388 ext 8199 whitney-cindy@hotmail.com
Contact: Xin Du, M.D., Ph.D. 0086-755-83366388 ext 8197 duxingz@medmail.com.cn

Locations
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China, Guangdong
Weihong Chen Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Weihong Chen, M.D.,Ph.D.    0086-755-83366388 ext 8199    whitney-cindy@hotmail.com   
Contact: Xin Du, M.D.,Ph.D.    0086-755-83366388 ext 8197    duxingz@medmail.com.cn   
Sponsors and Collaborators
Shenzhen Second People's Hospital
Investigators
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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 Institutes of Advanced Technology, Chinese Academy of Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT03685786    
Other Study ID Numbers: Weihong Chen06062018
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell