RecruitingPhase 1Phase 2NCT05338931

Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory 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


Sponsor

AbClon

Enrollment

82 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria7

  • 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 Criteria16

  • 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

Interventions

DRUGAT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Anti-CD19 Chimeric Antigen Receptor T cell


Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT05338931


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