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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05338931
Recruitment Status : Recruiting
First Posted : April 21, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
AbClon

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

Condition or disease Intervention/treatment Phase
B-cell Non Hodgkin Lymphoma Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell) Phase 1 Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : March 15, 2030
Estimated Study Completion Date : September 15, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Anti-CD19 Chimeric Antigen Receptor T cell
 Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Anti-CD19 Chimeric Antigen Receptor T cell
Other Name: AT101


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Concentration of cytokines [ Time Frame: 5 years ]
  2. CD19 expression [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338931


Contacts
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Contact: Young ha Lee 82-2-2109-1283 yhlee@abclon.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Deok-hyun Yoon         
Sponsors and Collaborators
AbClon
Investigators
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Principal Investigator: Deok-hyun Yoon Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
More Information
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Responsible Party: AbClon
ClinicalTrials.gov Identifier: NCT05338931    
Other Study ID Numbers: AbClon
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AbClon:
Anti-CD19 Chimeric Antigen Receptor T cell
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gossypol acetic acid
 Gossypol
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male