Clinical trial NCT05338931: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: B-cell Non Hodgkin Lymphoma
Keywords: Anti-CD19 Chimeric Antigen Receptor T cell
Lead sponsor: AbClon
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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:

  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

Primary outcomes:
measure: Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)
timeFrame: 28 days
measure: Overall response rate (ORR) by Independent assessment
timeFrame: 5 years
Secondary outcomes:
measure: Overall response rate (ORR) by Investigator assessment
timeFrame: 5 years
measure: Duration of overall response (DOR)
timeFrame: 5 years
measure: Overall survival(OS)
timeFrame: 5 years
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Time to response (TTR)
timeFrame: 5 years
measure: Event free survival (EFS)
timeFrame: 5 years
measure: Incidence of adverse Event
timeFrame: 5 years
measure: Peak concentration (Cmax) of AT101
timeFrame: 5 years
measure: Area under the concentration versus time curve (AUC) of AT101
timeFrame: 5 years
measure: AT101 transgene expression
timeFrame: 5 years
measure: Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase
timeFrame: 5 years
Other outcomes:
measure: Concentration of cytokines
timeFrame: 5 years
measure: CD19 expression
timeFrame: 5 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
name: Deok-hyun Yoon
role: PRINCIPAL_INVESTIGATOR
References: