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Safety and Efficacy Evaluation of CD19-UCART

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ClinicalTrials.gov Identifier: NCT03229876
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : May 27, 2021
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
Second Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Bioray Laboratories

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia (ALL) Non Hodgkin Lymphoma (NHL) Biological: CD19-UCART Not Applicable

Detailed Description:
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC.This is a open-label, dose estilation study to evaluate the safety and anti-tumor efficacy of CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 30, 2022


Arm Intervention/treatment
Experimental: CD19-UCART
All patients will be treated with 1 injection of CD19-UCART. Three escalating dose-levels (5x10^6/kgBW, 7x10^6/kgBW, 10x10^6/kgBW) of CD19-UCART will be evaluated using a 3+3 design. Each CD19-UCART injection will be administered at Day 0.
Biological: CD19-UCART
A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) occurence [ Time Frame: Baseline up to 35 days after T cell infusion ]
    Adverse events assessed according to NCI-CTCAE v4.03 criteria


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: At 12 weeks, and overall ]
    Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.

  2. Persistence of CART cells [ Time Frame: Assessed up to 3 months ]
    Duration of persistence of CD19-UCART cells after infusion will be detected by FACS or QPCR



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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously confirmed diagnosis as CD19+ ALL or NHL within18 months;
  2. ALL patients with the age between 6 and 30;or NHL patients between 16 and 65;
  3. Relapsed or refractory B-ALL or NHL;
  4. Expected survival >4W;
  5. ECOG <2;
  6. Have the capacity to give informed consent.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Isolated extramedullary relapse of ALL;
  3. Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
  4. With other type of maligant tumors in the past;
  5. Acceptance of allogeneic stem cell transplant (ASCT);
  6. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.

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): NCT03229876


Contacts
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Contact: Wei Li, phD +8602164340008 wli@bioraylab.com

Locations
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China, Henan
First Affliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Xinfeng Chen, PhD         
Principal Investigator: Yi Zhang, Professor         
China, Zhejiang
First Affliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Yongxian Hu, Prof    +8615957162012      
Sponsors and Collaborators
Bioray Laboratories
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
Second Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Yi Zhang, Professor First Affliated Hospital of Zhengzhou University
Principal Investigator: He Huang, Professor First Affliated Hospital of Zhejiang University
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Responsible Party: Bioray Laboratories
ClinicalTrials.gov Identifier: NCT03229876    
Other Study ID Numbers: 2018CAR-00CH1
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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