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

• ClinicalTrials.gov Identifier: NCT05338931
• Recruitment Status: Recruiting
• First Posted: April 21, 2022
• Last Update Posted: May 26, 2022
• Sponsor: AbClon
• Information provided by (Responsible Party): AbClon

Tracking Information

• First Submitted Date: April 1, 2022
• First Posted Date: April 21, 2022
• Last Update Posted Date: May 26, 2022
• Actual Study Start Date: March 15, 2022
• Estimated Primary Completion Date: March 15, 2030 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 14, 2022)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 14, 2022)

• Overall response rate (ORR) by Investigator assessment [ Time Frame: 5 years ]
  Proportion of subjects whose best overall response in tumor evaluation
• Duration of overall response (DOR) [ Time Frame: 5 years ]
  Time from first response (CR or PR) to the date of initial objectively documented progression
• Overall survival(OS) [ Time Frame: 5 years ]
  Time from randomization to death
• Progression free survival (PFS) [ Time Frame: 5 years ]
  Time from randomization to disease progression or death
• Time to response (TTR) [ Time Frame: 5 years ]
  Time from randomization to CR or PR
• Event free survival (EFS) [ Time Frame: 5 years ]
  Time from randomization to progression, subsequent chemotherapy or death
• 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 ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 14, 2022)

• Concentration of cytokines [ Time Frame: 5 years ]
• CD19 expression [ Time Frame: 5 years ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: B-cell Non Hodgkin Lymphoma

Intervention

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

Anti-CD19 Chimeric Antigen Receptor T cell

Other Name: AT101

Study Arms

Experimental: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Anti-CD19 Chimeric Antigen Receptor T cell

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 14, 2022): 82
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 15, 2030
• Estimated Primary Completion Date: March 15, 2030 (Final data collection date for primary outcome measure)

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:

  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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05338931
• Other Study ID Numbers: AbClon
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: AbClon
• Original Responsible Party: Same as current
• Current Study Sponsor: AbClon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deok-hyun Yoon; Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

• PRS Account: AbClon
• Verification Date: April 2022