Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma
Primary Purpose
Lymphoma, T-Cell
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Senl-T7
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, T-Cell
Eligibility Criteria
Inclusion Criteria:
- 1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;
Exclusion Criteria:
- 1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
Sites / Locations
- Hebei yanda Ludaopei HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD7 CAR-T
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CD7
Remission Rate
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
duration of response (DOR)
duration of response (DOR)
progression-free survival (PFS)
progression-free survival (PFS) time
CAR-T proliferation
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
CAR-T proliferation
percentage of CD7 CAR- T cells measured by flow cytometry method
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Secondary Outcome Measures
Full Information
NCT ID
NCT04928105
First Posted
June 9, 2021
Last Updated
May 24, 2022
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04928105
Brief Title
Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma
Official Title
Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 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 study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.
Detailed Description
Main research purposes:
To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma
Secondary research purpose:
To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD7 CAR-T
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Senl-T7
Intervention Description
Patients will be treated with CD7 CAR-T cells
Primary Outcome Measure Information:
Title
Safety: Incidence and severity of adverse events
Description
To evaluate the possible adverse events occurred within first one month after CD7
Time Frame
First 1 month post CAR-T cells infusion
Title
Remission Rate
Description
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Time Frame
3 months post CAR-T cells infusion
Title
duration of response (DOR)
Description
duration of response (DOR)
Time Frame
24 months post CAR-T cells infusion
Title
progression-free survival (PFS)
Description
progression-free survival (PFS) time
Time Frame
24 months post CAR-T cells infusion
Title
CAR-T proliferation
Description
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
Time Frame
3 months post CAR-T cells infusion
Title
CAR-T proliferation
Description
percentage of CD7 CAR- T cells measured by flow cytometry method
Time Frame
3 months post CAR-T cells infusion
Title
Cytokine release
Description
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Time Frame
First 1 month post CAR-T cells infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;
Exclusion Criteria:
1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peihua MD Lu, PhD
Phone
008618611636172
Email
peihua_lu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiang MD Li, PhD
Phone
008615511369555
Email
limmune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihua MD Lu, PhD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei yanda Ludaopei Hospital
City
Yanda
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua MD Lu, PhD
Phone
008618611636172
Email
peihua_lu@126.com
12. IPD Sharing Statement
Learn more about this trial
Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma
We'll reach out to this number within 24 hrs