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CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

Primary Purpose

Refractory Indolent Adult Non-Hodgkin Lymphoma

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CAR-T
CD22 CAR-T
CD19+CD22 CAR-T
Fludarabine
Cyclophosphamide
Sponsored by
Hebei Senlang Biotechnology Inc., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Indolent Adult Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
  2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.

    To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;

  3. There should be at least one measurable tumor focal point;
  4. Karnofsky [2] score 50 or more;
  5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
  6. The expected survival time is greater than 3 months;
  7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction<50;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other malignant tumor;
  4. Merging uncontrolled infection;
  5. Merging the metabolic diseases (except diabetes);
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. patients with active hepatitis B or hepatitis C;
  8. patients with HIV infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
  11. Pregnancy or lactation women;
  12. 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

volunteers

Arm Description

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma

Outcomes

Primary Outcome Measures

Number of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

Secondary Outcome Measures

Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Overall survival time
Overall survival time

Full Information

First Posted
November 6, 2020
Last Updated
November 11, 2020
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04626739
Brief Title
CAR-T Cells in Treating Patients With Relapsed or Refractory NHL
Official Title
An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Senlang Biotechnology Inc., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
Detailed Description
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
volunteers
Arm Type
Experimental
Arm Description
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma
Intervention Type
Drug
Intervention Name(s)
CD19 CAR-T
Other Intervention Name(s)
Senl_19
Intervention Description
CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
Intervention Type
Drug
Intervention Name(s)
CD22 CAR-T
Other Intervention Name(s)
Senl_22
Intervention Description
CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
Intervention Type
Drug
Intervention Name(s)
CD19+CD22 CAR-T
Other Intervention Name(s)
Senl_19+22
Intervention Description
CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
flu
Intervention Description
25mg/㎡ for D-4、D-3 and D-2
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
ctx
Intervention Description
500mg/㎡ for D-3 and D-2
Primary Outcome Measure Information:
Title
Number of Participants with Severe/Adverse Events as a Measure of Safety
Description
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time Frame
28 days
Title
CAR-T Cell expansion level
Description
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Objective response rate of complete remission and partial remission
Description
Objective response rate of complete remission and partial remission
Time Frame
24 months
Title
Overall survival time
Description
Overall survival time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet; Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology. To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment; There should be at least one measurable tumor focal point; Karnofsky [2] score 50 or more; Tumor cells were CD19 positive by immunohistochemistry or flow cytometry; The expected survival time is greater than 3 months; Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year; 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
86-311-82970975
Email
hr@senlangbio.com
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

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