Clinical Trials in South Korea / NCT05338931
Recruiting
Phase 1/2
Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
NCT05338931 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
B-cell Non Hodgkin Lymphoma
Investigational drug(s) / intervention(s)
AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
AT101(Anti-CD19 Chimeric Antigen Receptor T cell): Anti-CD19 Chimeric Antigen Receptor T cell
Study 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
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
Primary outcome measure(s)
- Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) — 28 days
Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials - Overall response rate (ORR) by Independent assessment — 5 years
Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05338931 on ClinicalTrials.gov ↗ ← All trials in South Korea