Back to resultsPhase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
Primary Purpose
T Cell Lymphoma, T-cell Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
chimeric antigen receptor T cell treatment
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
- Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
- Male or female, aged 0-70 years
- No serious allergic constitution
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
- Have life expectancy of at least 60 days based on investigator's judgement
- CD7 positive in bone marrow or peripheral blood or immunohistochemistry
- Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
- Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Intracranial hypertension or disorder of consciousness
- Symptomatic heart failure or severe arrhythmia
- Symptoms of severe respiratory failure
- Complicated with other types of malignant tumors
- Diffuse intravascular coagulation
- Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
- Suffering from septicemia or other uncontrollable infections
- Patients with uncontrollable diabetes
- Severe mental disorders
- Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
- Have received organ transplantation (excluding hematopoietic stem cell transplantation);
- Reproductive-aged female patients with positive blood HCG test
- Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
Sites / Locations
- Beijing Boren HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chimeric antigen receptor T cell treatment
Arm Description
Outcomes
Primary Outcome Measures
DLT rate
The DLT rate to the CAR-T treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04840875
Brief Title
Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
Official Title
Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
April 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Boren Hospital
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 a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma, T-cell Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chimeric antigen receptor T cell treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
chimeric antigen receptor T cell treatment
Intervention Description
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
Primary Outcome Measure Information:
Title
DLT rate
Description
The DLT rate to the CAR-T treatment
Time Frame
21 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
Male or female, aged 0-70 years
No serious allergic constitution
Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
Have life expectancy of at least 60 days based on investigator's judgement
CD7 positive in bone marrow or peripheral blood or immunohistochemistry
Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Intracranial hypertension or disorder of consciousness
Symptomatic heart failure or severe arrhythmia
Symptoms of severe respiratory failure
Complicated with other types of malignant tumors
Diffuse intravascular coagulation
Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
Suffering from septicemia or other uncontrollable infections
Patients with uncontrollable diabetes
Severe mental disorders
Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
Have received organ transplantation (excluding hematopoietic stem cell transplantation);
Reproductive-aged female patients with positive blood HCG test
Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Pan
Phone
+8618911067969
Email
panj@borenhospital.com
Facility Information:
Facility Name
Beijing Boren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Pan, Master
Phone
+8618911067969
Email
panj@borenhospital.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
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