Study on MB-105 for Patients with CD5 Positive T-cell Lymphoma

Sponsor: March Biosciences Inc

Sponsor score: 0

ClinicalTrials ID:NCT06534060

Provider View

This clinical trial is testing a new treatment called MB-105 for patients with a type of T-cell lymphoma that has returned or not responded to previous treatments. The study aims to find out if MB-105 is safe and effective in treating this condition.

Patient Parameters

Program Overview

This study is designed to evaluate the safety and effectiveness of MB-105, a new treatment for patients with CD5 Positive T-cell Lymphoma that has either come back or not responded to previous treatments. The trial will be conducted in two stages, enrolling a total of 46 patients. The first stage will involve 15 patients to assess the initial response and safety of the treatment. If successful, the study will proceed to the second stage with additional patients. The study will monitor patients' health and response to the treatment over time, with regular safety checks by an independent committee.

Description

The study will begin by enrolling 15 patients to receive MB-105 at a dose determined to be safe in earlier trials. After the first 6 patients have been treated and monitored for at least 30 days, an independent committee will review the safety data to confirm the appropriate dose for further evaluation. If the dose is confirmed, the study will continue to enroll 9 more patients to complete the first stage. The committee will then review all data to decide whether to proceed to the second stage, which will include 31 more patients, making a total of 46 participants.

Throughout the study, the committee will regularly review safety and effectiveness data. The study will conclude once all patients have been followed for at least 12 months after treatment. After the study ends, patients will be invited to participate in a long-term follow-up study to monitor their health over time.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with relapsed or refractory T-cell lymphoma, including specific subtypes that have not responded to previous treatments.
  • Must have tumor tissue available or be willing to undergo a biopsy.
  • Cancer cells must test positive for CD5.
  • Must have a performance status score of 70% or higher, indicating the ability to carry out daily activities.
  • Previous CAR T-cell therapy must have been completed more than 60 days before joining the study, with no evidence of ongoing CAR T-cell activity.
  • Must have measurable or detectable disease based on specific criteria.
  • Previous stem cell transplant must have been completed more than 60 days before joining the study.
  • Must have adequate bone marrow and organ function as determined by specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.

Exclusion Criteria

  • Certain types of T-cell lymphoma, such as Sezary syndrome.
  • Cannot undergo leukapheresis, a procedure to collect white blood cells.
  • Previous treatment with CD5-targeted therapy.
  • Active viral infections like HIV, hepatitis B, or hepatitis C, unless under control.
  • Active, uncontrolled infections requiring IV treatment.
  • History of other cancers unless disease-free for at least 2 years, with some exceptions.
  • Severe allergic reactions to certain proteins.
  • Active central nervous system lymphoma.
  • Severe graft versus host disease requiring ongoing treatment.
  • Recent use of systemic immunosuppressive therapy or donor lymphocyte infusions.
  • Medical conditions that could interfere with the study or treatment, such as recent heart attack or stroke, uncontrolled seizures, or severe psychiatric conditions.
  • History of autoimmune disorders, with some exceptions for mild cases.
  • Participation in other clinical trials within 30 days before joining this study.

Locations

FACILITYZIPCITYSTATE
Baylor College of Medicine77030HoustonTexas

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