T-Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
Conditions
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.
Interventions
BIOLOGICALThisCART7 cells
0.5-6 x 10\^6 CAR T cells per kg body weight
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Fundamenta Therapeutics, Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-related grade≥3Adverse Events or SAE | within 4 weeks after infusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 4 to 6 weeks after infusion | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival time | 3 years | The interval between administration and disease progression or death. |
| Overall survival time | 3 years | The interval between administration and death caused by any reason. |
| Event-free survival | 3 years | EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit. |
Countries
China
Contacts
Primary ContactLi Jun, Ph.D
Backup ContactHe Ling
Outcome results
None listed