Ongoing Trial

Phase 2 Trial Details

ClinicalTrials.gov ID: NCT06534060

Brief Summary

MB-105 study (NCT06534060), a Phase 2, open-label, single-arm, multicenter clinical trial for patients with CD5-positive relapsed or refractory T-cell lymphoma (r/r TCL). The study uses a Simon two-stage design.

Key Inclusion Requirements

  1. Male or female ≥ 18 years of age.
  2. Patients with r/r TCL per WHO 2022 criteria.
  3. Has available tumor tissue or willing to undergo biopsy procedure.
  4. CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT.

Key Exclusion Requirements

  1. Sezary syndrome. For other tumor types, if there is a suspicion of significant circulating disease at time of leukapheresis, discuss eligibility with medical monitor prior to proceeding.
  2. Contraindication to leukapheresis.
  3. Prior treatment with any CD5-targeted therapy.
  4. Any evidence of the following active viral infections:

Active Clinical Sites

Baylor College of Medicine
Houston, Texas, United States, 77030 Map

Contact: Brandon Garner
Email: bjgarner@texaschildrens.org
Phone: 832-824-4594
Principal Investigator: LaQuisa Hill, MD

MD Anderson Cancer Center
Houston, TX 77030 Map

Contact: Christine Samuel
Email: csamuel@mdanderson.org
Phone: 713-745-7143
Principal Investigator: Swaminathan Iyer, MD

University of Iowa
Iowa City, Iowa 52242 Map

Contact: Gail Nelson
Email: gail-nelson@uiowa.edu
Phone: 319-678-7922
Principal Ivestigator: Eric Mou, MD

Massachusetts General Hospital
Boston, MA 02114 Map

Contact: Michael Rabinovich
Phone: 617-724-9190
Principal Investigatory: Salvia Jain, MD