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CAR T Cells for Refractory B Cell Malignancy

Primary Purpose

B-Cell Leukemia, B-Cell Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous CD19-targeting CAR T cells
Sponsored by
Hebei Senlang Biotechnology Inc., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Leukemia

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The treat history meeting the following criteria:

    • Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
    • Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
    • One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
  2. There is a measurable lesions before treatment at least;
  3. ECOG score≤2;
  4. To be aged 1 to 70 years;
  5. More than a month lifetime from the consent signing date

Exclusion Criteria:

  • Serious cardiac insufficiency, left ventricular ejection fraction<50;
  • Has a history of severe pulmonary function damaging;
  • Merging other malignant tumor;
  • Merging uncontrolled infection;
  • Merging the metabolic diseases (except diabetes);
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • patients with active hepatitis B or hepatitis C;
  • patients with HIV infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Sites / Locations

  • No.2 Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19 CAR T cells

Arm Description

Autologous CD19-targeting CAR T cells

Outcomes

Primary Outcome Measures

Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures

CAR T cell persistence
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis

Full Information

First Posted
October 28, 2016
Last Updated
April 27, 2017
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02963038
Brief Title
CAR T Cells for Refractory B Cell Malignancy
Official Title
Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
The Second Hospital of Hebei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
Detailed Description
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Leukemia, B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD19 CAR T cells
Arm Type
Experimental
Arm Description
Autologous CD19-targeting CAR T cells
Intervention Type
Biological
Intervention Name(s)
Autologous CD19-targeting CAR T cells
Intervention Description
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
Primary Outcome Measure Information:
Title
Tumor load
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
CAR T cell persistence
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Time Frame
Up to 24 months
Other Pre-specified Outcome Measures:
Title
B cell number and immunoglobulins in peripheral blood
Description
The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The treat history meeting the following criteria: Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients. There is a measurable lesions before treatment at least; ECOG score≤2; To be aged 1 to 70 years; More than a month lifetime from the consent signing date Exclusion Criteria: Serious cardiac insufficiency, left ventricular ejection fraction<50; Has a history of severe pulmonary function damaging; Merging other malignant tumor; Merging uncontrolled infection; Merging the metabolic diseases (except diabetes); Merging severe autoimmune diseases or immunodeficiency disease; patients with active hepatitis B or hepatitis C; patients with HIV infection; Has a history of serious allergies on Biological products (including antibiotics); Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianqiang li, PhD & MD
Phone
+8631189928689
Email
limmune@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Luo, PhD & MD
Phone
+8631166002304
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD & MD
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.2 Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqiang Li, PhD & MD
Phone
+86311-89928689
Email
limmune@gmail.com
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD & MD
Phone
+86311-66002304
First Name & Middle Initial & Last Name & Degree
Jianmin Luo, PhD & MD
First Name & Middle Initial & Last Name & Degree
Jianqiang Li, PhD & MD

12. IPD Sharing Statement

Plan to Share IPD
No

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CAR T Cells for Refractory B Cell Malignancy

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