Refractory B-Cell Lymphoma
Conditions
Brief summary
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 iCAR NK cells in patients with relapsed refractory B cell lymphoma.
Interventions
BIOLOGICALAnti-CD19 iCAR NK Cells
Anti-CD19 iCAR NK Cells injection
Sponsors
Peking University Cancer Hospital & Institute
Allife Medical Science and Technology Co., 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. CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry 2. Previously accepted ≥ first-line regimen chemotherapy 3. Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation 4. Over 18 years old and under 70 years old 5. The expected survival period is more than 3 months. 6. ECOG≤2 7. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL; 8. Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L; 9. The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year. 10. Measurable target lesion
Exclusion criteria
1. Patients with extramedullary relapse 2. Burkitt's lymphoma/leukemia 3. Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment; 4. Liver and kidney function: * Total bilirubin \> 2 x ULN (Gilbert Syndrome \> 3 x ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN * Serum creatinine clearance \>60 mL/min 5. Serological examination: * Absolute neutrophil count (ANC) \<0.75x109/L * Platelet count (PLT) \<50x109/L 6. Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection 7. GVHD ≥ 2 or anti-GVHD treatment 8. IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion; 9. Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks 10. Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included); 11. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation 12. Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit 13. New York Heart Association (NYHA) graded above or above 14. Uncontrollable diabetes 15. Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining 16. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment related adverse events as assessed by CTCAE v4.0 | 1 year | Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. |
Outcome results
None listed