Evaluating AT101 for patients with relapsed B-cell Non-Hodgkin's Lymphoma
An Open-label, Single-arm, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 Chimeric Antigen Receptor T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
This study is testing a new treatment called AT101 to see if it can help people with relapsed B-cell non-Hodgkin's lymphoma feel better and how safe it is.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AbClon Industry-sponsored |
| Drugs / interventions | tocilizumab, chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05338931 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and efficacy of AT101, an anti-CD19 chimeric antigen receptor T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) for this patient population. Participants will be monitored for their response to the treatment and any adverse effects experienced during the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with B-cell non-Hodgkin lymphoma who have not responded to standard therapies or have experienced disease progression.
Not a fit: Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or those with certain contraindications to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited alternatives for relapsed or refractory B-cell non-Hodgkin lymphoma.
How similar studies have performed: Previous studies involving CAR T-cell therapies have shown promising results in treating various types of lymphoma, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Deok-hyun Yoon — Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
- Study coordinator: Young ha Lee
- Email: yhlee@abclon.com
- Phone: 82-2-2109-1283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.