Study on IOMAB-ACT and CAR-T Cell Therapy for Patients with Difficult or Returning Diffuse Large B-cell Lymphoma

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06768905

Provider View

This clinical trial is testing a new treatment approach using a radioactive drug, IOMAB-ACT, followed by CAR-T cell therapy to see if it is safe and effective for patients with Diffuse Large B-cell Lymphoma that has not responded to previous treatments or has come back.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a single dose of a radioactive drug called 131I-Apamistamab, given before CAR-T cell therapy, in patients with Diffuse Large B-cell Lymphoma (DLBCL) that has returned or not responded to treatment. The study will start with a small group of six patients to ensure safety before expanding to more participants.

Description

This study involves giving patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) a single dose of a radioactive drug, 131I-Apamistamab, before they receive CAR-T cell therapy. The goal is to see if this combination is safe and can help treat the cancer. The study will begin with a small group of six patients to monitor safety before including more participants. Patients will undergo various tests and procedures to ensure they meet the study criteria and to monitor their health throughout the treatment process.

Eligibility Criteria

Inclusion Criteria

  • Have Diffuse Large B-cell Lymphoma (DLBCL) or a related type of lymphoma that has returned or not responded to previous treatments.
  • Must have received at least one prior treatment that included specific chemotherapy and antibody therapy.
  • Have at least one tumor that can be measured by scans.
  • Be 18 years or older.
  • Have adequate kidney, liver, and lung function as determined by specific medical tests.
  • Have good bone marrow function, with certain blood cell counts above specified levels.
  • Be in relatively good overall health, with a performance status score between 0 and 2.
  • Agree to use effective birth control during the study and for 30 days after treatment.
  • Be able to understand and sign a consent form agreeing to participate in the study.
  • Undergo additional tests and meet specific criteria before receiving the radioactive drug and CAR-T cell therapy.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have significant heart problems, such as severe heart failure or recent heart attack.
  • Have active autoimmune diseases or require certain immune-suppressing medications.
  • Have active infections like HIV or hepatitis B or C, unless under specific conditions.
  • Have uncontrolled infections or other active cancers requiring treatment.
  • Have significant neurological disorders like epilepsy.
  • Have received certain types of radiation therapy or treatments with radiopharmaceuticals before.
  • Have specific antibodies that may interfere with the study treatment.
  • Have a prolonged QT interval on an ECG (QTcF greater than 470 milliseconds).

Locations

FACILITYZIPCITYSTATE
University of Texas Southwestern Medical Center75390DallasTexas

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