Back to resultsStudy of Anti-CD19 iCAR 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-CD19 iCAR 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-CD19 iCAR NK Cells
Arm Description
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
NCT03824951
First Posted
January 30, 2019
Last Updated
January 30, 2019
Sponsor
Allife Medical Science and Technology Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT03824951
Brief Title
Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Official Title
An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
Collaborators
Peking University Cancer Hospital & Institute
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 CD19 iCAR 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-CD19 iCAR NK Cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Anti-CD19 iCAR NK Cells
Intervention Description
Anti-CD19 iCAR 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
1 year
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 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
12. IPD Sharing Statement
Learn more about this trial
Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma
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