T-cell Non-Hodgkin Lymphoma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 24, 2023 |
Est. primary completion date | January 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. 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.); 2. No alternative treatment options deemed by investigator; 3. Measurable or detectble disease at time of enrollment; 4. Age 18-70 years old, no gender and race limited; 5. Eastern cooperative oncology group (ECOG) performance status of =2; 6. Cardiac ejection fraction = 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); 7. Estimated life expectancy > 12 weeks deemed by investigator; 8. Serum creatinine = 1.5 upper limit of normal (ULN); 9. Serum ALT/ AST = 5 upper limit of normal (ULN); 10. Signed informed consent form (ICF). Exclusion Criteria: 1. Women in pregnancy or lactation; 2. Uncontrolled infection; 3. Active hepatitis B virus or hepatitis C virus infection; 4. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease; 5. Prior treatment with an allogeneic stem cell transplant within 100 days; 6. Grade 2-4 Active graft versus host disease; 7. History of HIV infection; 8. With central nervous system involvement; 9. Patients combine with other disease cause neutrophil count (ANC) < 750/uL or PLT< 50,000/uL. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Hefei | Anhui |
China | Fundamenta Therapeutice Co.,Ltd | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Fundamenta Therapeutics, Ltd. | The First Affiliated Hospital of University of Science and Technology of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Progression free survival time | The interval between administration and disease progression or death. | 3 years | |
Other | Overall survival time | The interval between administration and death caused by any reason. | 3 years | |
Other | Event-free survival | EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit. | 3 years | |
Primary | 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). | within 4 weeks after infusion | |
Secondary | 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. |
4 to 6 weeks after infusion |
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