Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
Study Details
Study Description
Brief Summary
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ThisCART19 cells injections In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies. |
Biological: ThisCART19 cells
0.2-60 x 10^6 CAR T cells per kg body weight
|
Outcome Measures
Primary Outcome Measures
- Treatment related adverse events [90 days post infusion]
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Secondary Outcome Measures
- Overall Remission Rate (ORR) [up to 90 days]
Anti-tumor efficacy by 2014 Lugano criteria
- 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 (EFS) [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:
-
Age 18-70 years old, no gender and race limited;
-
Estimated life expectancy > 12 weeks deemed by investigator；
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CD19 were positive by histopathology and/or cytology diagnosis；
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Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
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Relevant indicators for disease or assessment within 4 weeks after the last treatment;
-
Quality of Life Score (KPS) >50%；
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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;
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No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
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Unsuitable conditions for stem cell transplantation;
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Signed informed consent form (ICF).
Exclusion Criteria:
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Women in pregnancy or lactation;
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In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
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The absolute count of nonprimary neutrophil < 0.75×109/L or platelet count < 50×109/L;
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Abnormal vital signs and failure to cooperate with examination;
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Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
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Highly allergic constitution or history of severe allergy;
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Patients with systemic infection or severe local infection requiring anti-infection treatment;
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Patients with severe autoimmune diseases;
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Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
Sponsors and Collaborators
- Fundamenta Therapeutics, Ltd.
- The Affiliated Hospital of Xuzhou Medical University
Investigators
- Study Chair: Zhengyu Li, Ph.D, The Affiliated Hospital of Xuzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FT400-002