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Recruiting NCT05338931

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

Phase I / Phase II Interventional B-cell Non Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AT101(Anti-CD19 Chimeric Antigen Receptor T cell).
Who it may be relevant to
Registry conditions: B-cell Non Hodgkin Lymphoma. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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).

Interventions

  • Drug AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
    Anti-CD19 Chimeric Antigen Receptor T cell

Primary outcome measures

  • Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) [Time frame: 28 days]
  • Overall response rate (ORR) by Independent assessment [Time frame: 5 years]
Secondary outcome measures (11)
  • Overall response rate (ORR) by Investigator assessment [Time frame: 5 years]
  • Duration of overall response (DOR) [Time frame: 5 years]
  • Overall survival(OS) [Time frame: 5 years]
  • Progression free survival (PFS) [Time frame: 5 years]
  • Time to response (TTR) [Time frame: 5 years]
  • Event free survival (EFS) [Time frame: 5 years]
  • Incidence of adverse Event [Time frame: 5 years]
  • Peak concentration (Cmax) of AT101 [Time frame: 5 years]
  • Area under the concentration versus time curve (AUC) of AT101 [Time frame: 5 years]
  • AT101 transgene expression [Time frame: 5 years]
  • Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase [Time frame: 5 years]

Eligibility 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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Publications

  • Zhang Y, Patel RP, Kim KH, Cho H, Jo JC, Jeong SH, Oh SY, Choi YS, Kim SH, Lee JH, Angelos M, Guruprasad P, Cohen I, Ugwuanyi O, Lee YG, Pajarillo R, Cho JH, Carturan A, Paruzzo L, Ghilardi G, Wang M, Kim S, Kim SM, Lee HJ, Park JH, Cui L, Lee TB, Hwang IS, Lee YH, Lee YJ, Porazzi P, Liu D, Lee Y, Kim JH, Lee JS, Yoon DH, Chung J, Ruella M. Safety and efficacy of a novel anti-CD19 chimeric antigen PMID 38066564

Identifiers

NCT: NCT05338931 · AbClon

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗