Last updated: April 5, 2021
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting
Phase
1
Condition
Hematologic Cancer
Leukemia
Lymphocytic Leukemia, Acute
Treatment
N/AClinical Study ID
NCT04796675
CAR-NK-CD19 cells
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged ≥ 18 years;
- Eastern Cooperative Oncology Group score≤ 3;
- Diagnosed as CD19+ B-cell hematological malignancies, including acute lymphoblasticleukemia, chronic lymphocytic leukemia and Non Hodgkin's lymphoma.
- Patients must relapse or be refractory after at least two lines of therapy.
- Patient's main organs functioning well: A. Liver function: alanine aminotransferase/aspartate aminotransferase < 2.5 times theupper limit of normal (ULN) and total bilirubin≤ 1.5 times ULN; B. Renal function:Creatinine clearance rate ≥ 60ml/min. C. Pulmonary function: Indoor oxygen saturation ≥ 95%. D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50%, noclinically-significant ECG findings.
- Negativity of blood pregnancy test for woman, and participants use effective methodsof contraception until last follow-up.
- Patient or his or her legal guardian voluntarily participates in and signs an informedconsent form.
Exclusion
Exclusion Criteria:
- Investigators judge the patients with gastrointestinal lymph node and/or centralnervous system involvement who may be at high-risk of receiving CAR-NK-CD19 celltreatment.
- Patients with graft-versus-host reaction and need immunosuppressive agents, orpatients with autoimmune diseases.
- Systemic steroids are used within 5 days before apheresis.
- Drugs to stimulate the production of bone marrow hematopoietic cells are used within 5days before apheresis.
- Patients receive cytotoxic chemotherapy or radiotherapy within 21 days beforeenrollment(Tyrosine kinase inhibitors or other targeted therapies can be used twoweeks before lymphodepleting chemotherapy).
- History of epilepsy or other central nervous system diseases.
- Participants with other active malignancies (except non-melanoma skin cancer andcervical cancer) within five years.
- Known HIV positive patients.
- Patients with active infections, including active replication of hepatitis B or activehepatitis C.
- Patients receive any antitumor treatments within 4 weeks before enrollment, and thetoxicity related to previous treatments don't return to < 1 level at enrollment (except for low grade toxicity such as alopecia).
- Major surgery in the past 4 weeks.
- Non-compliant patients.
- Anticoagulants are being used.
Study Design
Total Participants: 27
Study Start date:
April 10, 2021
Estimated Completion Date:
March 10, 2024
Study Description
Connect with a study center
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaActive - Recruiting

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