Status:
UNKNOWN
Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Shanghai Simnova Biotechnology Co.,Ltd.
Conditions:
Acute Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD19 chimeric antigen receptor(CAR)-modified NK cells(CAR-NK-CD19) in patients with relapsed o...
Detailed Description
Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy has shown remarkable clinical efficacy in B-cell cancers. However, CAR T cells can induce substantial toxic effects, and the manufacture of the...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years;
- Eastern Cooperative Oncology Group score≤ 3;
- Diagnosed as CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia, 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 the upper 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%, no clinically-significant ECG findings.
- Negativity of blood pregnancy test for woman, and participants use effective methods of contraception until last follow-up.
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
Exclusion
- Investigators judge the patients with gastrointestinal lymph node and/or central nervous system involvement who may be at high-risk of receiving CAR-NK-CD19 cell treatment.
- Patients with graft-versus-host reaction and need immunosuppressive agents, or patients 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 5 days before apheresis.
- Patients receive cytotoxic chemotherapy or radiotherapy within 21 days before enrollment(Tyrosine kinase inhibitors or other targeted therapies can be used two weeks before lymphodepleting chemotherapy).
- History of epilepsy or other central nervous system diseases.
- Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within five years.
- Known HIV positive patients.
- Patients with active infections, including active replication of hepatitis B or active hepatitis C.
- Patients receive any antitumor treatments within 4 weeks before enrollment, and the toxicity 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.
Key Trial Info
Start Date :
April 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04796675
Start Date
April 10 2021
End Date
March 10 2024
Last Update
April 8 2021
Active Locations (1)
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1
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022