Immunotherapy in Lymphoma

Sponsor
Sung-Soo Park
Study ID
NCT06796517
Status
Recruiting
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Conditions

  • Burkitt Lymphoma
  • Diffuse Large B Cell Lymphoma Relapsed
  • High Grade B-cell Lymphoma
  • Primary Mediastinal Large B-Cell Lymphoma
  • Relapsed/refractory High Grade B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
19 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • CAR-T Therapy — DRUG
    It uses the patient's own T cells, and requires a manufacturing process to modify and expand T cells before infusion. It directly targets B cell specific antigens, such as CD19 or CD20.
  • Bispecific antibody — DRUG
    It uses a dual targeting mechanism to enhance specificity and immune activation. It is an off-the-shelf treatment, and doesn't require a manufacturing process of patient cells.
  • Antibody-Drug Conjugate — DRUG
    It is a targeted therapy consisting of a monoclonal antibody linked to a cytotoxic drug. The antibody binds to a specific antigen on cancer cells, delivering the cytotoxic agent directly to the tumor, minimizing systemic toxicity.
  • Monoclonal antibody — DRUG
    Monoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.
  • Proteasome Inhibitor — DRUG
    It blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.
  • IMiD treatment — DRUG
    Immune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.

Study Details

The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is: Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies? Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes. Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.

Key Dates

First listed
Jan 28, 2025
Start date
Jun 26, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
72 participants (estimated)

Arms

  • Arm: Advanced immunochemotherapy
    Relapsed/refractory high grade B cell lymphoma patients treated with either chimeric antigen receptor T cell therapy, bispecific antibody, or antibody-drug conjugate
  • Arm: Classical Immunochemotherapy
    Relapsed/refractory high grade B cell lymphoma patients treated with either proteasome inhibitor, immune modulatory drug, or monoclonal antibody.

Primary Outcome Measure

Overall survival [ Time Frame: From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months. ]

Central Contacts

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