B-cell Non Hodgkin Lymphoma
Conditions
Keywords
Anti-CD19 Chimeric Antigen Receptor T cell
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).
Interventions
DRUGAT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Anti-CD19 Chimeric Antigen Receptor T cell
Sponsors
AbClon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of overall response (DOR) | 5 years | Time from first response (CR or PR) to the date of initial objectively documented progression |
| Overall survival(OS) | 5 years | Time from randomization to death |
| Progression free survival (PFS) | 5 years | Time from randomization to disease progression or death |
| Time to response (TTR) | 5 years | Time from randomization to CR or PR |
| 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 | — |
| Event free survival (EFS) | 5 years | Time from randomization to progression, subsequent chemotherapy or death |
| Overall response rate (ORR) by Investigator assessment | 5 years | Proportion of subjects whose best overall response in tumor evaluation |
Other
| Measure | Time frame |
|---|---|
| Concentration of cytokines | 5 years |
| CD19 expression | 5 years |
Countries
South Korea
Contacts
Primary ContactYoung ha Lee
Outcome results
None listed