Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART22 (Allogeneic CAR-T targeting CD22) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Detailed Description
-----------------
ThisCART22 cell is a non-gene-editing allogeneic CAR-T cell targeting CD22. This study is designed to evaluate the safety and clinical activity of ThisCART22 in patients with CD22 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).

Official Title
-----------------
An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22(ThisCART22) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)

Conditions
-----------------
B-cell Malignancy

Intervention / Treatment
-----------------
* Biological: ThisCART22 cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years old, no gender and race limited; Estimated life expectancy > 12 weeks deemed by investigator； CD22 were positive by histopathology and/or cytology diagnosis； Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)； Relevant indicators for disease or assessment within 4 weeks after the last treatment; Quality of Life Score (KPS) >50%； Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl; No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy; Unsuitable conditions for stem cell transplantation; Signed informed consent form (ICF). Exclusion Criteria: Women in pregnancy or lactation; In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection； The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L; Abnormal vital signs and failure to cooperate with examination; Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; Highly allergic constitution or history of severe allergy; Patients with systemic infection or severe local infection requiring anti-infection treatment; Patients with severe autoimmune diseases; Presence of any other conditions that are unsuitable for this study as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThisCART22 cells injections<br>In this study, allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies. | Biological: ThisCART22 cells<br>* 0.2-60 x 10^6 CAR T cells per kg body weight<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events | Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0 | 90 days post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Remission Rate (ORR) | Anti-tumor efficacy by 2014 Lugano criteria | up to 90 days | 
| Progression free survival time | The interval between administration and disease progression or death | 3 years | 
| Overall survival time | The interval between administration and death caused by any reason | 3 years | 
| Event-free survival (EFS) | EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit. | 3 years |