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Study of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690310
Recruitment Status : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Brief Summary:
This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma.

Condition or disease Intervention/treatment Phase
Refractory B-Cell Lymphoma Biological: Anti-CD19 CAR NK Cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Anti-CD19 CAR NK Cells
Total dose of 50-600 thousand /kg Anti-CD19 CAR NK cells will be administered at day0
Biological: Anti-CD19 CAR NK Cells
Anti-CD19 CAR NK Cells injection




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03690310    
Other Study ID Numbers: CD19 CAR NK-BJZL-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin