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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

Tracking Information
First Submitted Date  ICMJE July 19, 2017
First Posted Date  ICMJE July 26, 2017
Last Update Posted Date May 27, 2021
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • evaluation of study related adverse events [ Time Frame: Day1 to Week24 ]
    Monitor the occurrence of study related adverse events (defined Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are "possibly", "likely", or "definitely" related to study treatment any time from the first day of study treatment until week 24.
  • evaluation of CART persistence [ Time Frame: Day1 to Month6 ]
    Duration of in vivo survival of CD19-CART cells is defined as "engraftment". PCR for CD19-CART vector sequences will also be performed after infusion at 24 hours, weekly x 4, monthly x 6, and every 3 months thereafter until any 2 sequential tests are negative documenting loss of CART-19 cells.
  • evaluation of GVHD [ Time Frame: Day 14 to Day 42 ]
    Monitor possbile epithelial damage of target organs including skin, liver, gastrointestinal tract within 14-42 days
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
anti-tumor efficacy [ Time Frame: 2 years ]
Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Evaluation of CD19-UCART
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lymphoblastic Leukemia (ALL)
  • Non Hodgkin Lymphoma (NHL)
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: CD19-UCART
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wei Li, phD +8602164340008 wli@bioraylab.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229876
Other Study ID Numbers  ICMJE 2018CAR-00CH1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioray Laboratories
Study Sponsor  ICMJE Bioray Laboratories
Collaborators  ICMJE
  • The First Affiliated Hospital of Zhengzhou University
  • First Affiliated Hospital of Zhejiang University
  • Second Xiangya Hospital of Central South University
Investigators  ICMJE
Principal Investigator: Yi Zhang, Professor First Affliated Hospital of Zhengzhou University
Principal Investigator: He Huang, Professor First Affliated Hospital of Zhejiang University
PRS Account Bioray Laboratories
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP