Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- Conditions
- B-cell Non Hodgkin Lymphoma
- Interventions
- Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
- Registration Number
- NCT05338931
- Lead Sponsor
- AbClon
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 82
- 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
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Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
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At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
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Those who cannot take autologous blood
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Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
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Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
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Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
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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
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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
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Those who have been administered or applied to other IP/ID within 4 weeks of screening
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Those who are addicted to alcohol and/or medication
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Those who are unfit or unable to participate in this trial when judged by PI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AT101(Anti-CD19 Chimeric Antigen Receptor T cell) AT101(Anti-CD19 Chimeric Antigen Receptor T cell) Anti-CD19 Chimeric Antigen Receptor T cell
- Primary Outcome Measures
Name Time Method Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) 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 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
Name Time Method Peak concentration (Cmax) of AT101 5 years Progression free survival (PFS) 5 years Time from randomization to disease progression or death
Overall response rate (ORR) by Investigator assessment 5 years Proportion of subjects whose best overall response in tumor evaluation
Duration of overall response (DOR) 5 years Time from first response (CR or PR) to the date of initial objectively documented progression
Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase 5 years Overall survival(OS) 5 years Time from randomization to death
Time to response (TTR) 5 years Time from randomization to CR or PR
Event free survival (EFS) 5 years Time from randomization to progression, subsequent chemotherapy or death
Incidence of adverse Event 5 years AT101 transgene expression 5 years Area under the concentration versus time curve (AUC) of AT101 5 years
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of