Actively Recruiting
Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Led by AbClon · Updated on 2022-05-26
82
Participants Needed
1
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
CONDITIONS
Official Title
Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with B-cell non-Hodgkin lymphoma based on WHO classification 2017
- Disease is incompatible with existing standard therapies or has progressed, with no available standard treatments due to intolerance, inadequacy, or rejection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood, kidney, liver, lung, heart, and bone marrow function without blood transfusion within two weeks prior to screening
- Minimum life expectancy of 12 weeks or more
- Negative pregnancy tests in women of childbearing potential during the trial
- Voluntary written consent to participate in the trial
You will not qualify if you...
- History of treatment with allogeneic hematopoietic stem cell transplantation (HSCT)
- Prior use of AT101, other anticancer chemotherapy or lymphodepletion agents if hypersensitive to tocilizumab
- Unable to provide autologous blood
- Received chemotherapy or radiotherapy (excluding lymphodepletion) within two weeks prior to investigational product administration
- Not recovered (CTCAE grade 61 or baseline) from previous treatment
- Any condition that may affect safety or validity during the trial as judged by the investigator
- Clinical heart disease within 6 months prior to screening
- History of thromboembolic disease, pulmonary embolism, or bleeding disorders within 6 months prior to screening
- History of malignant tumors other than B-cell NHL within 5 years prior to screening
- Major surgery within 4 weeks prior to screening
- Non-critical surgery within 2 weeks prior to screening
- Women or men unwilling to use effective contraception during and for 12 months after treatment
- Administration of other investigational products within 4 weeks prior to screening
- Addiction to alcohol and/or medication
- Unfit or unable to participate as judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young ha Lee
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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