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Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL

Primary Purpose

Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-CD19-CAR
Sponsored by
Beijing Doing Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Lymphoma, CAR T

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 18 years to 70 years.
  5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
  6. Patients who have failed at least one line of a standard treatment.
  7. No serious mental disorder.
  8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
  9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  10. No other tumors.
  11. Patients volunteer to participate in the research.
  12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.

Exclusion Criteria:

  1. KPS<50.
  2. Patients are allergic to cytokines.
  3. Central nervous system leukemia within 28 days.
  4. Uncontrolled active infection.
  5. Acute or chronic GVHD.
  6. Treated with T cell inhibitor.
  7. Pregnancy and nursing females.
  8. HIV/HBV/HCV Infection.
  9. Other situations we think improper for the research.

Sites / Locations

  • Beijing Cancer Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • Hebei Yanda Ludaopei Hospital
  • First Affiliated Hospital of Henan University of Science and Technology
  • The First Affiliated Hospital of Zhengzhou University
  • Huai'An First People'S Hospital
  • Nanjing Drum Tower Hospital
  • First Hospital of Jilin University
  • Shanxi Dayi Hospital
  • Tianjin people's hospital
  • Hangzhou Cancer Hospital
  • Beijing DOING Biomedical Co., Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental: 1

Experimental: 2

Experimental: 3

Arm Description

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.

Outcomes

Primary Outcome Measures

Adverse events of each patient.
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures

Survival time of Anti-CD19 CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Antitumor Effects
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.

Full Information

First Posted
September 8, 2015
Last Updated
January 23, 2021
Sponsor
Beijing Doing Biomedical Co., Ltd.
Collaborators
The First Hospital of Jilin University, Hebei Yanda Ludaopei Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02546739
Brief Title
Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
Official Title
Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Doing Biomedical Co., Ltd.
Collaborators
The First Hospital of Jilin University, Hebei Yanda Ludaopei Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
Leukemia, Lymphoma, CAR T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 1
Arm Type
Experimental
Arm Description
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Arm Title
Experimental: 2
Arm Type
Experimental
Arm Description
Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Arm Title
Experimental: 3
Arm Type
Experimental
Arm Description
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Intervention Type
Biological
Intervention Name(s)
Anti-CD19-CAR
Intervention Description
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Primary Outcome Measure Information:
Title
Adverse events of each patient.
Description
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Survival time of Anti-CD19 CAR T cells in vivo.
Description
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time Frame
3 years
Title
Antitumor Effects
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time Frame
Every 3 months post treatment up to 24 months
Title
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Description
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma. KPS>60. Life expectancy>3 months. Gender unlimited, age from 18 years to 70 years. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. Patients who have failed at least one line of a standard treatment. No serious mental disorder. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L). No other serious diseases(autoimmune disease, immunodeficiency etc.). No other tumors. Patients volunteer to participate in the research. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial. Exclusion Criteria: KPS<50. Patients are allergic to cytokines. Central nervous system leukemia within 28 days. Uncontrolled active infection. Acute or chronic GVHD. Treated with T cell inhibitor. Pregnancy and nursing females. HIV/HBV/HCV Infection. Other situations we think improper for the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gai liyun, doctor
Phone
086-13269099630
Email
liyun_gai@doingtimes.com
First Name & Middle Initial & Last Name or Official Title & Degree
li gangyi
Phone
086-13901106501
Email
gangyi_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li gangyi, master
Organizational Affiliation
Beijing Doing Biomedical Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Hebei Yanda Ludaopei Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gai liyun, Doctor
Phone
086-13269099630
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Huai'An First People'S Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shanxi Dayi Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Tianjin people's hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li gangyi, Master
Phone
13601204100
Email
gangyi_li@doingtimes.com
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Facility Name
Beijing DOING Biomedical Co., Ltd
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

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Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL

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