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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
Sponsor
AbClon
Phase
Phase 1/2
Started
2022-03-15
Last updated
2022-05-26

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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Asan Medical Center Seoul South Korea Recruiting
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