- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692767
Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
January 29, 2019 updated by: Allife Medical Science and Technology Co., Ltd.
An Observational Clinical Study on the Safety and Efficacy of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
9
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anti-CD22 CAR NK cells
Total dose of 50-600 thousand /kg Anti-CD22 CAR NK cells will be administered at day0
|
Anti-CD22 CAR NK Cells injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of treatment related adverse events as assessed by CTCAE v4.0
Time Frame: Day 3-Year 2 after injection
|
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
|
Day 3-Year 2 after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2019
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
November 1, 2021
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
September 29, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD22 CAR NK-BJZL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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David Bond, MDRecruitingRecurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent... and other conditionsUnited States
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Clinical Trials on Anti-CD22 CAR NK Cells
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