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

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

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

Study Overview

• Status: Recruiting
• Conditions: B-cell Non Hodgkin Lymphoma
• Intervention / Treatment: Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

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
• Enrollment (Anticipated): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Young ha Lee; Phone Number: 82-2-2109-1283; Email: yhlee@abclon.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Deok-hyun Yoon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: AT101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)	Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials	28 days
Overall response rate (ORR) by Independent assessment	Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR) by Investigator assessment	Proportion of subjects whose best overall response in tumor evaluation	5 years
Duration of overall response (DOR)	Time from first response (CR or PR) to the date of initial objectively documented progression	5 years
Overall survival(OS)	Time from randomization to death	5 years
Progression free survival (PFS)	Time from randomization to disease progression or death	5 years
Time to response (TTR)	Time from randomization to CR or PR	5 years
Event free survival (EFS)	Time from randomization to progression, subsequent chemotherapy or death	5 years
Incidence of adverse Event		5 years
Peak concentration (Cmax) of AT101		5 years
Area under the concentration versus time curve (AUC) of AT101		5 years
AT101 transgene expression		5 years
Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase		5 years

Other Outcome Measures

Outcome Measure	Time Frame
Concentration of cytokines	5 years
CD19 expression	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): March 15, 2030
• Study Completion (Anticipated): September 15, 2030

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Anti-CD19 Chimeric Antigen Receptor T cell
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents, Male; Spermatocidal Agents; Antispermatogenic Agents; Gossypol; Gossypol acetic acid
• Other Study ID Numbers: AbClon

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No