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The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

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: NCT02924753
Recruitment Status : Unknown
Verified December 2017 by Yongping Song, Henan Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2016
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
The Beijing Pregene Science and Technology Company, Ltd.
Information provided by (Responsible Party):
Yongping Song, Henan Cancer Hospital

Study Description
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Brief Summary:
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Drug: Cyclophosphamide Drug: Fludarabine Biological: CART-19 cells Phase 1

Detailed Description:

Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
Actual Study Start Date : July 18, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
 Drug: Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

Drug: Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).

Biological: CART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Other Name: CD19 specific Chimeric Antigen Receptor T-cells


Outcome Measures
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Primary Outcome Measures :
  1. safety as assessed by the occurrence of study related adverse events. [ Time Frame: 6 months ]
    monitor the occurrence of study related adverse events.


Secondary Outcome Measures :
  1. efficacy [ Time Frame: 2 years ]
    anti-tumor activity of CART-19 cells will be determined in a follow-on study

  2. duration of CART-19 [ Time Frame: 2 years ]
    Determine duration of in vivo survival of CART-19 cells.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 4 years to 70 years, expected survival > 3 months
  2. CD19 positive B-cell acute lymphoblastic leukemia
  3. Karnofsky Performance Status (KPS) >70
  4. Relapsed after allogeneic or autologous stem cell transplantation (SCT);
  5. Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
  6. No serious allergic constitution
  7. No other serous diseases that conflicts with the clinical program
  8. No other cancer history
  9. No serious mental disorder
  10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
  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. Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN
  7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products
  8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
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): NCT02924753


Contacts
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Contact: Yongping Song ph200811@163.com

Locations
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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Yongping Song       ph200811@163.com   
Sponsors and Collaborators
Henan Cancer Hospital
The Beijing Pregene Science and Technology Company, Ltd.
Investigators
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Study Director: Yongping Song Henan Cancer Hospital
More Information
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Responsible Party: Yongping Song, director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT02924753    
Other Study ID Numbers: HenanCH080
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists