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

RECRUITINGPHASE1/PHASE2

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

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

NCT05338931•AbClon

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

March 15, 2022

Primary Completion Date

March 15, 2030

Completion Date

September 15, 2030

Last Updated

May 26, 2022

Enrollment

ESTIMATED participants

Conditions

B-cell Non Hodgkin Lymphoma

Interventions

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

DRUG

Contacts

Young ha Lee

CONTACT

82-2-2109-1283 yhlee@abclon.com

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

NCT06365671

B-cell Non Hodgkin Lymphoma

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RECRUITINGPHASE1

Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL

NCT06707259

B-cell Non Hodgkin Lymphoma

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RECRUITINGPHASE1

Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors

Clinical Study of Cord Blood-derived IL-10/IL-15 CD19-CAR NK in the Treatment of Refractory/Relapsed B-cell NHL

Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

MargheRITA (Remote Intelligence for Therapeutic Adherence)

Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL

A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- NHL