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Study of Safety and Efficacy of C-CAR011 in B-NHL Patients

Primary Purpose

Refractory or Relapsed Non-Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
C-CAR011
Sponsored by
Cellular Biomedicine Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory or Relapsed Non-Hodgkin Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Volunteered to participate in this study and signed informed consent
  2. Age 18-70 years old, male or female
  3. Relapsed or refractory B cell non-Hodgkin's lymphoma

    • 1 Histologically diagnosed as DLBCL(including PMBCL) or follicular lymphoma(grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (1st edition 2017)

      1. Progressive disease after the last standard chemotherapy regimens
      2. Stable disease after the last standard chemotherapy regimens
      3. Relapsed within 12 months after prior autologous SCT
    • 2 Follicular lymphoma(stage Ⅲ-Ⅳ)(grade Ⅰ-Ⅲa)

      1. At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
      2. Less than 1 year between last chemotherapy and progression
    • 3 Mantle cell lymphoma

      1. Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
      2. Disease relapsed or progressed after most recent therapy
      3. Relapsed within 12 months after prior autologous SCT
  4. All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)
  5. At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
  6. Expected survival ≥ 12 weeks
  7. ECOG score 0-1
  8. Adequate pulmonary, hepatic, renal and cardiac function
  9. At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy therapy) prior to leukapheresis,or at least 4 weeks from monoclonal antibody therapy prior to CAR T infusion
  10. No contraindications of leukapheresis
  11. Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial

Exclusion Criteria:

  1. Prior treatment with CAR T therapy or any other genetically modified T cell therapy
  2. Relapse after allogeneic hematopoietic stem cell transplantation
  3. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  4. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people
  5. Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications
  6. QT interval prolongation≥450 ms
  7. A history of epilepsy or other central nervous system disorders
  8. No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
  9. The patient had a history of other primary cancers, with the following exceptions

    • 1 Excisional non-melanoma such as cutaneous basal cell carcinoma
    • 2 Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer
  10. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  11. Used of systemic steroids within two weeks (using inhaled steroids is an exception)
  12. Women who are pregnant or lactating or have breeding intent in 6 months
  13. Participated in any other clinical trial within three months
  14. The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Sites / Locations

  • Department of Hematology,Shanghai Tongji Hospital, Tongji University School of MedicinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-CAR011

Arm Description

Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene

Outcomes

Primary Outcome Measures

Safety(Incidence of adverse events)
Incidence of adverse events (AEs)
Objective response rate (ORR)

Secondary Outcome Measures

Objective response rate (ORR)
Duration of remission(DOR)
Progression free survival(PFS)
Overall survival(OS)

Full Information

First Posted
May 13, 2017
Last Updated
May 13, 2017
Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03154775
Brief Title
Study of Safety and Efficacy of C-CAR011 in B-NHL Patients
Official Title
Study of Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T Cell(C-CAR011) Treatment in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Detailed Description
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation; Lymphodepleting Chemotherapy), Treatment and Follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory or Relapsed Non-Hodgkin Lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
C-CAR011
Arm Type
Experimental
Arm Description
Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
Intervention Type
Biological
Intervention Name(s)
C-CAR011
Other Intervention Name(s)
Anti-CD19 Chimeric Antigen Receptor T cell
Intervention Description
Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
Primary Outcome Measure Information:
Title
Safety(Incidence of adverse events)
Description
Incidence of adverse events (AEs)
Time Frame
12 weeks
Title
Objective response rate (ORR)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
12 months
Title
Duration of remission(DOR)
Time Frame
12 months
Title
Progression free survival(PFS)
Time Frame
12 months
Title
Overall survival(OS)
Time Frame
12 months

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: Volunteered to participate in this study and signed informed consent Age 18-70 years old, male or female Relapsed or refractory B cell non-Hodgkin's lymphoma 1 Histologically diagnosed as DLBCL(including PMBCL) or follicular lymphoma(grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (1st edition 2017) Progressive disease after the last standard chemotherapy regimens Stable disease after the last standard chemotherapy regimens Relapsed within 12 months after prior autologous SCT 2 Follicular lymphoma(stage Ⅲ-Ⅳ)(grade Ⅰ-Ⅲa) At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy Less than 1 year between last chemotherapy and progression 3 Mantle cell lymphoma Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT Disease relapsed or progressed after most recent therapy Relapsed within 12 months after prior autologous SCT All subjects must have received adequate prior therapy including anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and an anthracycline containing chemotherapy regimen. The standardized treatment regimens reference to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1) At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm) Expected survival ≥ 12 weeks ECOG score 0-1 Adequate pulmonary, hepatic, renal and cardiac function At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy therapy) prior to leukapheresis,or at least 4 weeks from monoclonal antibody therapy prior to CAR T infusion No contraindications of leukapheresis Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial Exclusion Criteria: Prior treatment with CAR T therapy or any other genetically modified T cell therapy Relapse after allogeneic hematopoietic stem cell transplantation Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected people Patients with class III and IV heart failure according to the NYHA Heart Failure Classifications QT interval prolongation≥450 ms A history of epilepsy or other central nervous system disorders No evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging The patient had a history of other primary cancers, with the following exceptions 1 Excisional non-melanoma such as cutaneous basal cell carcinoma 2 Cured in situ carcinoma such as cervical cancer, bladder cancer or breast cancer Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy Used of systemic steroids within two weeks (using inhaled steroids is an exception) Women who are pregnant or lactating or have breeding intent in 6 months Participated in any other clinical trial within three months The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aibin Liang, MD,Ph.D.
Phone
0086-021-66111019
Email
lab7182@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Li, MD,Ph.D.
Phone
0086-021-66111015
Email
lilyforever76@126.com
Facility Information:
Facility Name
Department of Hematology,Shanghai Tongji Hospital, Tongji University School of Medicin
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aibin Liang, MD,Ph.D.
Phone
0086-021-66111019
Email
lab7182@tongji.edu.cn
First Name & Middle Initial & Last Name & Degree
Ping Li, MD,Ph.D.
Phone
0086-021-66111015
Email
lilyforever76@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of Safety and Efficacy of C-CAR011 in B-NHL Patients

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