Study on CD30 CAR T-Cell Therapy After Stem Cell Transplant for High-Risk Hodgkin Lymphoma

Sponsor: New York Medical College

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06617286

Provider View

This clinical trial is exploring a new treatment approach for patients with high-risk classical Hodgkin Lymphoma. It involves using a patient's own modified immune cells, called CD30 CAR T-cells, after they have undergone a stem cell transplant.

Patient Parameters

Program Overview

The study aims to test a new treatment for patients with high-risk classical Hodgkin Lymphoma. Participants will first receive intense chemotherapy and a stem cell transplant using their own cells. After recovering from the transplant, they will receive an infusion of their own immune cells that have been specially modified to target and attack cancer cells. This treatment is called CD30 CAR T-cell therapy.

Description

In this study, patients with high-risk classical Hodgkin Lymphoma will undergo a series of treatments. First, they will be screened to ensure they qualify for the study. If eligible, their blood cells will be collected and sent to a lab to create CD30 CAR T-cells. These are immune cells that have been modified to better fight cancer.

Next, patients will have their own stem cells collected and stored. They will then receive intense chemotherapy, known as myeloablative chemotherapy, followed by a stem cell transplant using their stored cells. This process is called autologous stem cell transplantation (AutoHSCT).

After the transplant, patients will be monitored and, if they meet the criteria, will receive an infusion of their CD30 CAR T-cells about 3 to 6 weeks later. This is to help their immune system target and destroy any remaining cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Age between 6 and 29 years old.
  • Have a performance score of 60% or higher, indicating the ability to carry out daily activities.
  • Diagnosed with CD30+ classical Hodgkin Lymphoma and eligible for a stem cell transplant.
  • Must have experienced one of the following: failure to respond to initial treatment, disease progression, or disease relapse (up to the third time).
  • Must have a confirmed biopsy showing the presence of CD30+ Hodgkin Lymphoma before joining the study.
  • Must have at least two of the following risk factors:
    • Performance score below 90%.
    • Relapse occurred within one year of initial diagnosis.
    • Cancer spread outside the lymph nodes at relapse.
    • High tumor volume as shown by specific imaging tests.
    • Cancer that did not respond to initial re-treatment.

Exclusion Criteria

  • Not meeting the inclusion criteria.

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