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CD19-CAR-T Cells in Patients With R/R 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: NCT03574168
Recruitment Status : Unknown
Verified June 2018 by Bioceltech Therapeutics, Ltd..
Recruitment status was:  Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bioceltech Therapeutics, Ltd.

Study Description
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Brief Summary:
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Biological: CD19-CAR-T Cells Phase 1

Detailed Description:

Primary objective:

To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.

Secondary objective:

To Assess the patient's quality of life after receiving the treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
Estimated Study Start Date : July 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CD19-CAR-T Cells
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
 Biological: CD19-CAR-T Cells
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate, ORR [ Time Frame: Up to Day90 after the CD19-CAR-T cell infusion ]

    The percentage of participants who achieved complete remission (CR) over all participants (CRR).

    The percentage of participants who achieved partial remission (PR) over all participants (PRR).



Secondary Outcome Measures :
  1. The amount of CAR-T cells remaining in vivo [ Time Frame: 2 years after cell infusion. ]
    Measure and analyze monthly

  2. The lifetime of CAR-T cells remaining in vivo [ Time Frame: 2 years after cell infusion. ]
    Measure and analyze monthly


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
  2. Age 3-70 years old;
  3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
  4. B cells are positive for CD19 expression;
  5. Peripheral blood tumor cell load <50%; 6. KPS score >50 points;

7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

Exclusion Criteria:

  1. Patients with non-B cell acute leukemia;
  2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
  3. Active infection;
  4. Human immunodeficiency virus (HIV) positive;
  5. Acute and chronic graft-versus-host disease (GVHD)> Level 1；
  6. Pregnant or lactating women;
  7. Patients do not agree to use effective contraception during the treatment period and following 3 months;
  8. Patients who participated in other clinical studies at the same time;
  9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
  10. Long-term use greater doses of hormones than physiological doses.
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): NCT03574168


Contacts
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Contact: Zhongwei Xu, MD, Phd +86 010-69739722 willyxu001@bioceltech.com

Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital Recruiting
Langfang, Hebei, China, 065000
Contact: Peihua Lu, MD, PhD    18611636172    peihua_lu@126.com   
Sponsors and Collaborators
Bioceltech Therapeutics, Ltd.
Investigators
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Principal Investigator: Peihua Lu, MD, PhD Hebei Yanda Ludaopei Hospital
More Information
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Responsible Party: Bioceltech Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT03574168    
Other Study ID Numbers: BT-ALL-001-v2
ChiCTR1800016541 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases