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NCT Number: NCT05338931

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asan Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Deok-hyun Yoon

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Drug

Anti-CD19 Chimeric Antigen Receptor T cell

Other names: AT101

Primary outcomes

  1. Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)

    Time frame: 28 days

    Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials

  2. Overall response rate (ORR) by Independent assessment

    Time frame: 5 years

    Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response

Secondary outcomes

  1. Overall response rate (ORR) by Investigator assessment

    Time frame: 5 years

    Proportion of subjects whose best overall response in tumor evaluation

  2. Duration of overall response (DOR)

    Time frame: 5 years

    Time from first response (CR or PR) to the date of initial objectively documented progression

  3. Overall survival(OS)

    Time frame: 5 years

    Time from randomization to death

  4. Progression free survival (PFS)

    Time frame: 5 years

    Time from randomization to disease progression or death

  5. Time to response (TTR)

    Time frame: 5 years

    Time from randomization to CR or PR

  6. Event free survival (EFS)

    Time frame: 5 years

    Time from randomization to progression, subsequent chemotherapy or death

  7. Incidence of adverse Event

    Time frame: 5 years

  8. Peak concentration (Cmax) of AT101

    Time frame: 5 years

  9. Area under the concentration versus time curve (AUC) of AT101

    Time frame: 5 years

  10. AT101 transgene expression

    Time frame: 5 years

  11. Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase

    Time frame: 5 years

Other outcomes

  1. Concentration of cytokines

    Time frame: 5 years

  2. CD19 expression

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Young ha Lee

CONTACT

[email protected]

82-2-2109-1283

Sponsors and collaborators

Lead sponsor

AbClon

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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