B-cell Malignancy
Conditions
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).
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).
Interventions
BIOLOGICALThisCART19 cells
0.2-60 x 10\^6 CAR T cells per kg body weight
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Fundamenta Therapeutics, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years old, no gender and race limited; 2. Estimated life expectancy \> 12 weeks deemed by investigator； 3. CD19 were positive by histopathology and/or cytology diagnosis； 4. Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)； 5. Relevant indicators for disease or assessment within 4 weeks after the last treatment; 6. Quality of Life Score (KPS) \>50%； 7. 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; 8. No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy; 9. Unsuitable conditions for stem cell transplantation; 10. Signed informed consent form (ICF).
Exclusion criteria
1. Women in pregnancy or lactation; 2. In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection； 3. The absolute count of nonprimary neutrophil \< 0.75×10\^9/L or platelet count \< 50×10\^9/L; 4. Abnormal vital signs and failure to cooperate with examination; 5. Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; 6. Highly allergic constitution or history of severe allergy; 7. Patients with systemic infection or severe local infection requiring anti-infection treatment; 8. Patients with severe autoimmune diseases; 9. Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment related adverse events | 90 days post infusion | Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJun Li, Ph.D
Outcome results
None listed