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Safety and Efficacy Evaluation of CD19-UCART

Sponsor
Bioray Laboratories (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03229876
Collaborator
The First Affiliated Hospital of Zhengzhou University (Other), First Affiliated Hospital of Zhejiang University (Other), Second Xiangya Hospital of Central South University (Other)
20
Enrollment
2
Locations
1
Arm
43
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: CD19-UCART
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Dose Limiting Toxicities (DLTs) occurence [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 [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 [Assessed up to 3 months]

    Duration of persistence of CD19-UCART cells after infusion will be detected by FACS or QPCR

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
2 First Affliated Hospital of Zhejiang University Hangzhou Zhejiang China 310003

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

  • Principal Investigator: Yi Zhang, Professor, First Affliated Hospital of Zhengzhou University
  • Principal Investigator: He Huang, Professor, First Affliated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bioray Laboratories
ClinicalTrials.gov Identifier:
NCT03229876
Other Study ID Numbers:
  • 2018CAR-00CH1
First Posted:
Jul 26, 2017
Last Update Posted:
Apr 5, 2022
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Apr 5, 2022