Back to resultsSafety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
Primary Purpose
T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ThisCART7 cells
Sponsored by
About this trial
This is an interventional treatment trial for T-Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
- No alternative treatment options deemed by investigator;
- Measurable or detectble disease at time of enrollment;
- Age 18-70 years old, no gender and race limited;
- Eastern cooperative oncology group (ECOG) performance status of ≤2;
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
- Estimated life expectancy > 12 weeks deemed by investigator;
- Serum creatinine ≤ 1.5 upper limit of normal (ULN);
- Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
- Signed informed consent form (ICF).
Exclusion Criteria:
- Women in pregnancy or lactation;
- Uncontrolled infection;
- Active hepatitis B virus or hepatitis C virus infection;
- Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
- Prior treatment with an allogeneic stem cell transplant within 100 days;
- Grade 2-4 Active graft versus host disease;
- History of HIV infection;
- With central nervous system involvement;
- Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.
Sites / Locations
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)Recruiting
- Fundamenta Therapeutice Co.,LtdRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ThisCART7 cells injections
Arm Description
In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.
Outcomes
Primary Outcome Measures
Incidence of Treatment-related grade≥3Adverse Events or SAE
Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Secondary Outcome Measures
Objective Response Rate
Description:
For T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ;
For lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria.
Full Information
NCT ID
NCT05127135
First Posted
November 9, 2021
Last Updated
November 9, 2021
Sponsor
Fundamenta Therapeutics, Ltd.
Collaborators
The First Affiliated Hospital of University of Science and Technology of China
1. Study Identification
Unique Protocol Identification Number
NCT05127135
Brief Title
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
Official Title
A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
January 24, 2023 (Anticipated)
Study Completion Date
December 24, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundamenta Therapeutics, Ltd.
Collaborators
The First Affiliated Hospital of University of Science and Technology of China
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 is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
Detailed Description
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10^6 cells per kg body weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ThisCART7 cells injections
Arm Type
Experimental
Arm Description
In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.
Intervention Type
Biological
Intervention Name(s)
ThisCART7 cells
Intervention Description
0.5-6 x 10^6 CAR T cells per kg body weight
Primary Outcome Measure Information:
Title
Incidence of Treatment-related grade≥3Adverse Events or SAE
Description
Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time Frame
within 4 weeks after infusion
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Description:
For T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ;
For lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria.
Time Frame
4 to 6 weeks after infusion
Other Pre-specified Outcome Measures:
Title
Progression free survival time
Description
The interval between administration and disease progression or death.
Time Frame
3 years
Title
Overall survival time
Description
The interval between administration and death caused by any reason.
Time Frame
3 years
Title
Event-free survival
Description
EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
No alternative treatment options deemed by investigator;
Measurable or detectble disease at time of enrollment;
Age 18-70 years old, no gender and race limited;
Eastern cooperative oncology group (ECOG) performance status of ≤2;
Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
Estimated life expectancy > 12 weeks deemed by investigator;
Serum creatinine ≤ 1.5 upper limit of normal (ULN);
Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
Signed informed consent form (ICF).
Exclusion Criteria:
Women in pregnancy or lactation;
Uncontrolled infection;
Active hepatitis B virus or hepatitis C virus infection;
Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
Prior treatment with an allogeneic stem cell transplant within 100 days;
Grade 2-4 Active graft versus host disease;
History of HIV infection;
With central nervous system involvement;
Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Jun, Ph.D
Phone
+86-18662604088
Email
jli@ctigen.com
First Name & Middle Initial & Last Name or Official Title & Degree
He Ling
Phone
+86-18626100886
Email
lhe@ctigen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Xingbing
Organizational Affiliation
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingbing Wang
Phone
+86-18056075256
Email
wangxingbing@ustc.edu.cn
Facility Name
Fundamenta Therapeutice Co.,Ltd
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li
Phone
+8618662604088
Email
jli@ctigen.com
First Name & Middle Initial & Last Name & Degree
Ling He
Phone
+8618626100886
Email
lhe@ctigen.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
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