Actively Recruiting
An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-11-19
13
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
S
SupermAb (BeiJing) Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine whether AcNK-Sup003 cell injection is safe and effective in the treatment of elapsed or refractory B-cell non-Hodgkin's lymphoma.
CONDITIONS
Official Title
An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Age 18 years or older with expected survival over 3 months
- Confirmed CD20-positive relapsed or refractory B-cell non-Hodgkin's lymphoma by pathology
- Relapsed or refractory after prior therapies including CD20-targeted and anthracycline drugs
- ECOG performance status between 0 and 2
- Agree to use effective contraception if of childbearing potential; negative pregnancy test for women
- At least one measurable lymphoma lesion by Lugano 2014 criteria with positive FDG-PET scan
- Hemoglobin 80 g/L or higher, absolute neutrophil count 1.0x10^9/L or higher, platelet count 50x10^9/L or higher
- Coagulation tests within specified limits; INR ≤1.5×ULN or 2.0-3.0 if on anticoagulants
- Liver, kidney, and lung function within specified safe ranges
- Blood oxygen saturation 92% or higher without oxygen support
You will not qualify if you...
- Primary central nervous system lymphoma or active CNS involvement
- Active autoimmune diseases or moderate to severe graft-versus-host disease recently
- Severe heart or brain blood vessel diseases including serious arrhythmias, prolonged QT interval, recent acute coronary events, heart failure NYHA class II or higher, or uncontrolled hypertension
- Recent autologous or allogeneic stem cell or organ transplants
- Recent anti-tumor treatments or participation in other clinical studies
- Recent live vaccines or major surgeries
- Need for long-term systemic corticosteroids above specified dose
- History of other cancers except certain localized or treated types
- Recent serious infections needing systemic treatment
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Severe allergies or hypersensitivity to study drugs
- Pregnant or breastfeeding women
- Any other conditions affecting study compliance or suitability as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
H
Heng Mei, Ph.D&M.D
CONTACT
J
Jia Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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