Status:
UNKNOWN
Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Lead Sponsor:
Allife Medical Science and Technology Co., Ltd.
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Conditions:
Refractory B-Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
- Previously accepted ≥ first-line regimen chemotherapy
- Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
- Over 18 years old and under 70 years old
- The expected survival period is more than 3 months.
- ECOG≤2
- 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;
- Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
- 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.
- Measurable target lesion
Exclusion
- Patients with extramedullary relapse
- Burkitt's lymphoma/leukemia
- Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
- 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
- Serological examination:
- Absolute neutrophil count (ANC) \<0.75x109/L
- Platelet count (PLT) \<50x109/L
- Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection
- GVHD ≥ 2 or anti-GVHD treatment
- IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
- Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
- Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included);
- Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
- Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit
- New York Heart Association (NYHA) graded above or above
- Uncontrollable diabetes
- Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
- Any situation that the investigator believes may increase the risk of the subject or interfere with the test results
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03824951
Start Date
February 1 2019
End Date
January 1 2021
Last Update
January 31 2019
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