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MB-105 in Patients with CD5 Positive Relapsed/Refractory T-Cell Lymphoma

The purpose of this study is to find out how safe and effective a new CAR-T study treatment, called MB-105, is for people with T-cell lymphoma. MB-105 is an experimental study treatment. This means it is not approved for general use by the U.S. Food and Drug Administration (FDA) and, as such, can only be used in research studies.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

Your participation in this study includes the time from which you sign the consent form, through the completion of the 24 month follow up. During this time, you will need to visit the study clinic on a regular basis for study treatment, tests and exams. The study has five key time periods: • Screening: many tests during screening are repeated during study time periods and would be part of your standard cancer treatment. A biopsy will be performed during screening if tissue is not already available. • Creation of MB-105 (manufacturing): a blood collection procedure called apheresis will occur in order to make your MB-105. • Study Treatment: this includes conditioning therapy (administration of chemotherapy agents Cyclophosphamide and Fludarabine), anti-viral therapy (administration of anti-viral medicine Rituximab), and MB-105 study treatment. • Post-dose Safety monitoring: 4-week period after the MB-105 infusion for safety assessments. • Follow-up period: you will be checked on regularly in the 24 months after your MB-105 IV infusion. After the 24-month follow-up period, we will ask you to join another study. In this 'long-term follow-up' study we would like to monitor you regularly for up to 15 years. This will involve us contacting you every year to see how you are managing. You do not have to join the 15-year follow-up study to be part of this study.

Incentives

If you have to travel far to the study clinic, we may help to pay for travel, food, and hotel costs.

In-person visits:
Variable - based on disease and side effects
Phone or online visits:
Variable - based on worsened disease
Total length of participation:
112 Weeks

Looking for Specific Volunteers

Able to participate:

  • Patients with relapsed/refractory peripheral T cell lymphoma or relapsed/refractory cutaneous T cell lymphoma
  • Has available tumor tissue or willing to undergo biopsy procedure
  • CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT

Not eligible if:

  • Sezary syndrome
  • Contraindication to leukapheresis
  • Prior treatment with any CD5-targeted therapy
  • Active viral infections as specified in the protocol

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Anne Beaven
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

24-2095

ClinicalTrials.gov

NCT06534060

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