Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies

Conditions
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T-Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma, T-cell Acute Lymphoblastic Lymphoma

Intervention / Treatment
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* Biological: ThisCART7 cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThisCART7 cells injections<br>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<br>* 0.5-6 x 10^6 CAR T cells per kg body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |