NCT05338931 Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
| NCT ID | NCT05338931 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AbClon |
| Condition | B-cell Non Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2030-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 82 participants in total. It began in 2022-03-15 with a primary completion date of 2030-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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: 1. Those who have been clinically aware of heart disease within 6 months prior to screening 2. Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening 3. Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening 4. Those who have undergone major surgery within 4 weeks prior to screening 5. 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
Contact & Investigator
Deok-hyun Yoon
PRINCIPAL INVESTIGATOR
Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Frequently Asked Questions
Who can join the NCT05338931 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying B-cell Non Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05338931 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05338931 currently recruiting?
Yes, NCT05338931 is actively recruiting participants. Contact the research team at yhlee@abclon.com for enrollment information.
Where is the NCT05338931 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05338931 clinical trial?
NCT05338931 is sponsored by AbClon. The principal investigator is Deok-hyun Yoon at Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea. The trial plans to enroll 82 participants.