Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT101(Anti-CD19 Chimeric Antigen Receptor T cell) | Experimental | Anti-CD19 Chimeric Antigen Receptor T cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT101(Anti-CD19 Chimeric Antigen Receptor T cell) | Drug | Anti-CD19 Chimeric Antigen Receptor T cell |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of cytokines | 5 years | |
| CD19 expression | 5 years |
Inclusion Criteria:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young ha Lee | Contact | 82-2-2109-1283 | yhlee@abclon.com |
| Name | Affiliation | Role |
|---|---|---|
| Deok-hyun Yoon | Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38066564 | Derived | Zhang Y, Patel RP, Kim KH, Cho H, Jo JC, Jeong SH, Oh SY, Choi YS, Kim SH, Lee JH, Angelos M, Guruprasad P, Cohen I, Ugwuanyi O, Lee YG, Pajarillo R, Cho JH, Carturan A, Paruzzo L, Ghilardi G, Wang M, Kim S, Kim SM, Lee HJ, Park JH, Cui L, Lee TB, Hwang IS, Lee YH, Lee YJ, Porazzi P, Liu D, Lee Y, Kim JH, Lee JS, Yoon DH, Chung J, Ruella M. Safety and efficacy of a novel anti-CD19 chimeric antigen receptor T cell product targeting a membrane-proximal domain of CD19 with fast on- and off-rates against non-Hodgkin lymphoma: a first-in-human study. Mol Cancer. 2023 Dec 9;22(1):200. doi: 10.1186/s12943-023-01886-9. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C028178 | gossypol acetic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |