MB-105 in Patients With CD5 Positive T-cell Lymphoma

NCT06534060 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MB-105-201
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 12

Brief Summary

This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.

Conditions

Lymphoma, T-Cell

Keywords

MB-105-201

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  Incidence, severity, causal relationship of AEs

  26 months

• Objective response rate (ORR)

  Best objective response rate (ORR) per independent central review as defined by rate of complete response (CR) and PR using the 2014 Lugano criteria and 2022 Global criteria.

  26 months

Secondary Outcomes (4)

• Duration of response (DOR)

  26 months

• Progression-free survival (PFS)

  26 months

• Incidence of adverse events during the safety monitoring period for acute toxicities

  26 months

• Overall survival (OS)

  26 months

Study Arms (1)

Single arm

OTHER

This is a single arm, two-stage, Phase 2, open-label, multicenter study.

Biological: Genetic: MB-105

Interventions

Genetic: MB-105 BIOLOGICAL

MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Patients with r/r TCL per WHO 2022 criteria.
• r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy.
• r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin.
• Has available tumor tissue or is willing to undergo a biopsy procedure.
• CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT. CD5 positivity is currently defined as having ≥ 50% CD5 expression. An exploratory cohort will enroll patients with CD5 expression below 50%.
• Karnofsky performance score ≥ 70% or higher.
• Prior CAR T-cell therapy must have occurred \> 60 days prior to study enrollment and must have no evidence of CAR persistence.
• Measurable or detectable disease
• PTCL per Lugano criteria
• CTCL per Global (ISCL/EORTC/USCCL) criteria.
• Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) must have occurred more than 60 days prior to study enrollment.
• Adequate bone marrow function defined as:
• Absolute neutrophil count (ANC) ≥ 1500/μL (≥ 1000/μL for patients with prior HSCT or marrow involvement)
• Absolute lymphocyte count ≥200 cells/μL

You may not qualify if:

• 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.
• Contraindication to leukapheresis.
• Prior treatment with any CD5-targeted therapy.
• Any evidence of the following active viral infections:
• HIV infection.
• Chronic hepatitis B virus (cHBV) infection with detectable viral load. Patients with cHBV, who are receiving anti-viral prophylaxis, may be enrolled if they are asymptomatic for \>5 days prior to signing informed consent (ICF).
• Hepatitis C (HCV) infection with detectable viral load. Patients cured of HCV may be enrolled.
• Presence of any active, uncontrolled systemic bacterial, viral or fungal infection requiring intravenous (IV) anti-infectives, including clinically significant viral infection or uncontrolled viral reactivation of Epstein-Barr virus, Cytomegalovirus, Adenovirus, BK-virus, or Human herpesvirus 6. If treated with anti-infective agents, patients must be asymptomatic for \>5 days prior to enrollment.
• History of any malignancy within 2 years with the exception of cured stage 1 cancers or CIS and potentially indolent cancers not requiring active treatment or controlled with hormone therapy. Discuss patients with indolent cancers with the medical monitor.
• History of hypersensitivity reactions to products containing murine proteins.
• Active CNS lymphoma.
• Evidence of acute graft versus host disease (aGVHD) \> Grade 2 Mount Sinai Acute GVHD International Consortium (MAGIC) or chronic GVHD \> mild (NIH) requiring ongoing systemic steroids and/or multiagent therapy.
• Patients who have received systemic immunosuppressive therapy for treatment of GVHD within 28 days of leukapheresis.
• Patients who have received donor lymphocyte infusions within 28 days of MB-105 infusion.
• Comorbidity that would impair the patient's ability to receive or tolerate MB-105 and/or affect participation in the study:

Sponsors & Collaborators

• March Biosciences Inc: lead

Study Sites (12)

University of San Diego (UCSD)-Moores Cancer Center

San Diego, California, 92037, United States

RECRUITING

SCRI - Colorado Blood Cancer Institute (CBCI)

Denver, Colorado, 92037, United States

NOT YET RECRUITING

Moffitt Cancer Center Magnolia Campus

Tampa, Florida, 33612, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Nebraska

Omaha, Nebraska, 68198, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Oregan Health & Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alice Bexon, MD, CMO

  March Bio

  STUDY CHAIR

Central Study Contacts

Federica Giordano, Ph.D.

CONTACT

7138980838; clinicaltrials@march.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 2, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (12)