Back to resultsStudy of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Primary Purpose
Refractory B-Cell Lymphoma
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Anti-CD22 CAR NK Cells
Sponsored by
About this trial
This is an interventional treatment trial for Refractory B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Patients with extra-medullary 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 × ULN (Gilbert Syndrome > 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN Serum creatinine clearance >60 mL/min
Serological examination:
Absolute neutrophil count (ANC) <0.75×109/L Platelet count (PLT) <50×109/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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-CD22 CAR NK cells
Arm Description
Total dose of 50-600 thousand /kg Anti-CD22 CAR NK cells will be administered at day0
Outcomes
Primary Outcome Measures
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03692767
First Posted
September 28, 2018
Last Updated
January 29, 2019
Sponsor
Allife Medical Science and Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03692767
Brief Title
Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Official Title
An Observational Clinical Study on the Safety and Efficacy of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD22 CAR NK cells in patients with relapsed refractory B cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-CD22 CAR NK cells
Arm Type
Experimental
Arm Description
Total dose of 50-600 thousand /kg Anti-CD22 CAR NK cells will be administered at day0
Intervention Type
Biological
Intervention Name(s)
Anti-CD22 CAR NK Cells
Intervention Description
Anti-CD22 CAR NK Cells injection
Primary Outcome Measure Information:
Title
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
Description
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time Frame
Day 3-Year 2 after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Patients with extra-medullary 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 × ULN (Gilbert Syndrome > 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN Serum creatinine clearance >60 mL/min
Serological examination:
Absolute neutrophil count (ANC) <0.75×109/L Platelet count (PLT) <50×109/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
12. IPD Sharing Statement
Learn more about this trial
Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
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