Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ThisCART7 cells injections 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. |
Biological: ThisCART7 cells
0.5-6 x 10^6 CAR T cells per kg body weight
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Hefei | Anhui | China | |
| 2 | Fundamenta Therapeutice Co.,Ltd | Suzhou | Jiangsu | China |
Sponsors and Collaborators
- Fundamenta Therapeutics, Ltd.
- The First Affiliated Hospital of University of Science and Technology of China
Investigators
- Principal Investigator: Wang Xingbing, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ThisCART7