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

B-cell Non Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338931
• Other study ID #: AbClon
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 15, 2022
• Est. completion date: September 15, 2030

Study information

• Verified date: April 2022
• Source: AbClon
• Contact: Young ha Lee
• Phone: 82-2-2109-1283
• Email: yhlee[@]abclon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 15, 2030
• Est. primary completion date: March 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-cell Non Hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AbClon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of cytokines		5 years
Other	CD19 expression		5 years
Primary	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
Primary	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	Overall response rate (ORR) by Investigator assessment	Proportion of subjects whose best overall response in tumor evaluation	5 years
Secondary	Duration of overall response (DOR)	Time from first response (CR or PR) to the date of initial objectively documented progression	5 years
Secondary	Overall survival(OS)	Time from randomization to death	5 years
Secondary	Progression free survival (PFS)	Time from randomization to disease progression or death	5 years
Secondary	Time to response (TTR)	Time from randomization to CR or PR	5 years
Secondary	Event free survival (EFS)	Time from randomization to progression, subsequent chemotherapy or death	5 years
Secondary	Incidence of adverse Event		5 years
Secondary	Peak concentration (Cmax) of AT101		5 years
Secondary	Area under the concentration versus time curve (AUC) of AT101		5 years
Secondary	AT101 transgene expression		5 years
Secondary	Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase		5 years