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

NCT05338931 | Recruiting Phase 1

• 1 other identifier: AbClon
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Non Hodgkin Lymphoma

Keywords

Anti-CD19 Chimeric Antigen Receptor T cell

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Overall response rate (ORR) by Investigator assessment

  5 years

• Duration of overall response (DOR)

  5 years

• Overall survival(OS)

  5 years

• Progression free survival (PFS)

  5 years

• Time to response (TTR)

  5 years

Other Outcomes (2)

• Concentration of cytokines

  5 years

• CD19 expression

  5 years

Study Arms (1)

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

EXPERIMENTAL

Anti-CD19 Chimeric Antigen Receptor T cell

Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Interventions

AT101(Anti-CD19 Chimeric Antigen Receptor T cell) DRUG

Anti-CD19 Chimeric Antigen Receptor T cell

Also known as: AT101

AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• AbClon: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 38066564 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Deok-hyun Yoon

  Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young ha Lee

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 21, 2022
• Study Start: March 15, 2022
• Primary Completion (Estimated): March 15, 2030
• Study Completion (Estimated): September 15, 2030
• Last Updated: May 26, 2022

Record last verified: 2022-04

Locations

KR (1)