Contacts

Jun Li, Ph.D

CONTACT

18662604088 [email protected]

Sponsors

Lead Sponsor

Fundamenta Therapeutics, Ltd.

Collaborators

The Affiliated Hospital of Xuzhou Medical University

Age

18 - 70 years

Sex

ALL

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.

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Contacts

Sponsors

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