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

Primary Purpose

B-cell Non Hodgkin Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

About this trial

This is an interventional treatment trial for B-cell Non Hodgkin Lymphoma focused on measuring Anti-CD19 Chimeric Antigen Receptor T cell

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Arm Description

Anti-CD19 Chimeric Antigen Receptor T cell

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Overall response rate (ORR) by Investigator assessment

Proportion of subjects whose best overall response in tumor evaluation

Duration of overall response (DOR)

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

Overall survival(OS)

Time from randomization to death

Progression free survival (PFS)

Time from randomization to disease progression or death

Time to response (TTR)

Time from randomization to CR or PR

Event free survival (EFS)

Time from randomization to progression, subsequent chemotherapy or death

Incidence of adverse Event

Peak concentration (Cmax) of AT101

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

AT101 transgene expression

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

Full Information

NCT ID

NCT05338931

First Posted

April 1, 2022

Last Updated

May 24, 2022

Sponsor

AbClon

1. Study Identification

Unique Protocol Identification Number

NCT05338931

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

March 15, 2030 (Anticipated)

Study Completion Date

September 15, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbClon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Non Hodgkin Lymphoma

Keywords

Anti-CD19 Chimeric Antigen Receptor T cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Arm Type

Experimental

Arm Description

Anti-CD19 Chimeric Antigen Receptor T cell

Intervention Type

Drug

Intervention Name(s)

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Other Intervention Name(s)

AT101

Intervention Description

Anti-CD19 Chimeric Antigen Receptor T cell

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

28 days

Title

Overall response rate (ORR) by Independent assessment

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Overall response rate (ORR) by Investigator assessment

Description

Proportion of subjects whose best overall response in tumor evaluation

Time Frame

5 years

Title

Duration of overall response (DOR)

Description

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

Time Frame

5 years

Title

Overall survival(OS)

Description

Time from randomization to death

Time Frame

5 years

Title

Progression free survival (PFS)

Description

Time from randomization to disease progression or death

Time Frame

5 years

Title

Time to response (TTR)

Description

Time from randomization to CR or PR

Time Frame

5 years

Title

Event free survival (EFS)

Description

Time from randomization to progression, subsequent chemotherapy or death

Time Frame

5 years

Title

Incidence of adverse Event

Time Frame

5 years

Title

Peak concentration (Cmax) of AT101

Time Frame

5 years

Title

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

Time Frame

5 years

Title

AT101 transgene expression

Time Frame

5 years

Title

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

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Concentration of cytokines

Time Frame

5 years

Title

CD19 expression

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Young ha Lee

Phone

82-2-2109-1283

yhlee@abclon.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deok-hyun Yoon

Organizational Affiliation

Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deok-hyun Yoon

12. IPD Sharing Statement

Learn more about this trial

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

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