Actively Recruiting

Phase 1
Phase 2
Age: 19Years +
All Genders
ID05338931

Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 CAR T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Led by AbClon · Updated on 2022-05-26

82

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and maximum tolerated dose of AT101, an Anti-CD19 Chimeric Antigen Receptor T cell therapy, in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (B-cell NHL). This study aims to determine the recommended dose for phase 2 trials and assess the therapy's efficacy in patients who have limited or no response to standard treatments. Participants receive AT101, a specialized cell therapy targeting CD19 on B-cells. This open-label, single-arm study involves administering AT101 and monitoring patients over a period to find the appropriate dose level that balances safety and effectiveness. The study includes both phase 1 and phase 2 components to evaluate dose tolerance and clinical response. During the trial, participants will undergo various assessments including safety evaluations, laboratory tests, and measurements of overall response rate by independent and investigator assessments over up to five years. Researchers will monitor adverse events, survival rates, and pharmacokinetics of AT101. The total participation timeline includes close monitoring for 28 days post-dose for dose determination, followed by long-term follow-up for up to five years to assess treatment outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with B-cell Non-Hodgkin Lymphoma based on WHO classification 2017
  • Disease is incompatible with standard therapies or has progressed after them
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate blood, kidney, liver, lung, heart, and bone marrow function without blood transfusion within two weeks before screening
  • Life expectancy of at least 12 weeks
  • Negative pregnancy test in women of childbearing potential during the trial
  • Voluntary written agreement to participate in the trial
Not Eligible

You will not qualify if you...

  • History of allogeneic hematopoietic stem cell transplantation
  • Hypersensitivity to tocilizumab or prior treatment with AT101 or similar therapies
  • Unable to provide autologous blood
  • Received chemotherapy or radiotherapy (excluding lymphodepletion) within two weeks before investigational product administration
  • Not recovered to grade 1 or baseline from previous treatment side effects
  • Conditions affecting safety or trial validity as judged by the investigator
  • History of heart disease, thromboembolic disease, pulmonary embolism, bleeding disorders within six months before screening
  • History of other malignant tumors within five years before screening
  • Major surgery within four weeks or non-critical surgery within two weeks before screening
  • Childbearing individuals unwilling to use effective contraception during and after the trial
  • Received other investigational products within four weeks before screening
  • Alcohol or drug addiction
  • Deemed unfit or unable to participate by the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 28 days

Participants receive the AT101 (Anti-CD19 Chimeric Antigen Receptor T cell) therapy to determine the maximum tolerated dose and assess safety, tolerability, and efficacy.

Follow-up

Duration - 5 years

Participants are monitored for overall response, survival outcomes, and adverse events for up to 5 years after treatment.

Trial Site Locations

Total: 1 location

1

Asan Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

Y

Young ha Lee

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Yunlin Zhang, Ruchi P Patel, Ki Hyun Kim...

https://pubmed.ncbi.nlm.nih.gov/38066564