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Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllAibin Liang,MD,Ph.D.
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In plain words

What the trial is, and whether it could suit you

To find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily participate in the study and sign the informed consent; 2. Age 18-75, male and female; 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), and other Indolent B-cell NHL transforming types: (A) Relapsed or Refractory DLBCL and tFL after 2 lines Immunotherapy or chemotherapy ; (B) Definition of Refractory large B cell lymphoma (SCHOLAR - 1 Research Standard) : disease progression after more than 4 courses of standard Immunotherapy or chemotherapy; Or the time of disease stabilization ≤ 6 months; Or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation (auto-HSCT); (C) Relapsed or Refractory MCL must be 1 line with immune chemotherapy; BTK inhibitors are resistant or intolerant as 2-line therapy; (D) Relapsed or Refractory disease after chemotherapy including rituximab and anthracycline. 4. There was at least one measurable lesion with the longest diameter ≥ 1.5cm; 5. Estimated life expectancy of more than 12 weeks other than primary disease; 6. Previously confirmed diagnosis as CD19+ or CD70+ B-NHL. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3. 8. Adequate reserve of organ function: (A) Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤2.5 times the Upper Limit of Normal (ULN) for age; (B) A creatinine clearance (as estimated either by a direct urine collection or Cockcroft-Gault Equation) \> 60mL/min; (C) Total bilirubin and alkaline phosphatase ≤1.5 times the Upper Limit of Normal (ULN) for age; (D) glomerular filtration rate \> 50 ml/min (E) Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA); (F) Baseline oxygen saturation \>92% on room air (G) Absolute neutrophil count \> 1000/μL, Platelet count \> 45,000/μL ,Hemoglobin \> 80g/L; 9. Once previous autologous hematopoietic stem cell transplantation (auto-HSCT) is allowed; 10. For systemic therapy(Such as systemic chemotherapy, systemic radiotherapy and immunotherapy), at least 3 weeks,for Targeted drug therapy alone,at least 2 weeks,must have elapsed at the time of cell infusion; 11. Either having failed or Relapsed after CAR-T therapy at 3 months of assessment; 12. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study. Women of childbearing potential must have a negative serum or urine pregnancy test. 13. The viral load of severe coronavirus disease 2019 (COVID-19) is undetectable per quantitative PCR and/or nucleic acid testing for two tests. Exclusion Criteria: 1. Allergic to any of the components of cell products; 2. Previous or concurrent of other type of maligant tumors; 3. Acute GvHD or generalized chronic GvHD with grade II-IV (Glucksberg standard) after previous autologous hematopoietic stem cell transplantation (auto-HSCT); Or receiving of anti-GVHD therapy; 4. Known history of systemic gene therapy within the prior 3 months; 5. Active systemic fungal, viral, or bacterial infection (except for simple urinary tract infections and bacterial pharyngitis), however, Preventive treatment is permitted; 6. Known history of infection with hepatitis B (HBsAg positive, but HBV-DNA\<1000 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV infection; 7. Class III or IV heart failure as defined by the New York Heart Association; 8. Persisting toxicities (\>grade 1, except for clinically non-significant toxicities such as alopecia, fatigue, and anorexia) due to prior trerapy; 9. Known history of active seizures or presence of seizure activities or other central nervous system disease; 10. Have evidence of central nervous system lymphoma(CNS lymphoma) on CT or MRI; 11. Breast-feeding woman; 12. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.
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What it tests

  • dualCAR-NK19/70 cell
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Where

1 site
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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