Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

  • STATUS
    Recruiting
  • End date
    Sep 15, 2030
  • participants needed
    82
  • sponsor
    AbClon
Updated on 4 June 2022
blood transfusion

Summary

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.

Description

Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).

Details
Condition B-cell Non Hodgkin Lymphoma
Treatment AT101, AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Clinical Study IdentifierNCT05338931
SponsorAbClon
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
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
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