Status:
RECRUITING
Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
AbClon
Conditions:
B-cell Non Hodgkin Lymphoma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
Detailed Description
Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-...
Eligibility Criteria
Inclusion
- B cell non-Hodgkin lymphoma based on WHO classification 2017
- incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
- Those with a minimum life expectancy of 12 weeks or more
- In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
- Those who have agreed in writing to participate voluntarily in this trial
Exclusion
- Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
- At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
- Those who cannot take autologous blood
- Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
- Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
- Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
- Those who have identified the following forces at the time of screening:
- Those who have been clinically aware of heart disease within 6 months prior to screening
- Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
- Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
- Those who have undergone major surgery within 4 weeks prior to screening
- Those who have undergone non-critical surgery within two weeks prior to screening
- Childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and AT101 administration or when AT101 in the body is not identified
- Those who have been administered or applied to other IP/ID within 4 weeks of screening
- Those who are addicted to alcohol and/or medication
- Those who are unfit or unable to participate in this trial when judged by PI
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2030
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05338931
Start Date
March 15 2022
End Date
September 15 2030
Last Update
May 26 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea