Actively Recruiting
MB-105 in Patients With CD5 Positive T-cell Lymphoma
Led by March Biosciences Inc · Updated on 2025-10-03
46
Participants Needed
12
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MB-105 in Patients With CD5 Positive T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of relapsed or refractory T-cell lymphoma per WHO 2022 criteria
- For relapsed/refractory cutaneous T-cell lymphoma (CTCL), failure of 2 or more prior standard treatments
- For relapsed/refractory peripheral T-cell lymphoma (PTCL), failure of 1 or more prior standard treatment; patients with CD30+ disease must have received brentuximab vedotin
- Available tumor tissue or willingness to undergo biopsy
- CD5 positivity confirmed by local lab with at least 50% CD5 expression (exploratory cohort for less than 50%)
- Karnofsky performance score of 70% or higher
- Prior CAR T-cell therapy more than 60 days before enrollment without evidence of CAR persistence
- Measurable or detectable disease per lymphoma criteria
- Prior stem cell transplant more than 60 days before enrollment
- Adequate bone marrow function: ANC ≥1500/µL (or ≥1000/µL if prior transplant or marrow involvement), lymphocytes ≥200/µL, hemoglobin ≥8 g/dL (transfusion allowed), platelets ≥75,000/µL (or ≥50,000/µL if marrow involvement)
- Adequate organ function including cardiac ejection fraction ≥50%, oxygen saturation ≥92%, creatinine clearance >30 mL/min, liver function within specified limits, and albumin >2.5 g/dL
- For females of childbearing potential, negative pregnancy test and use of effective contraception with barrier method during and for 12 months after treatment
- For males, use of effective contraception with barrier method during and for 12 months after treatment
You will not qualify if you...
- Diagnosis of Sezary syndrome or suspicion of significant circulating disease at leukapheresis
- Contraindication to leukapheresis
- Prior treatment with any CD5-targeted therapy
- Active infections including HIV, chronic hepatitis B with detectable viral load, or hepatitis C with detectable viral load (cured HCV allowed)
- Active uncontrolled bacterial, viral, or fungal infections requiring intravenous treatment
- History of malignancy within 2 years except certain cured or indolent cancers
- History of hypersensitivity to products containing murine proteins
- Active central nervous system lymphoma
- Acute graft versus host disease above specified severity or chronic graft versus host disease requiring ongoing systemic steroids or multiagent therapy
- Recent systemic immunosuppressive therapy for graft versus host disease
- Current systemic corticosteroid treatment above 10 mg/day prednisone equivalent without appropriate washout
- Recent donor lymphocyte infusions
- Significant comorbidities impairing treatment tolerance or study participation including recent serious cardiovascular or cerebrovascular events, uncontrolled CNS disorders, or serious medical or psychiatric conditions
- History of autoimmune disorders except controlled thyroid disease with possible exemptions
- Participation in another interventional clinical trial treatment within 30 days before enrollment
- Prior bendamustine treatment without interim allogenic stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of San Diego (UCSD)-Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
2
SCRI - Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States, 92037
Not Yet Recruiting
3
Moffitt Cancer Center Magnolia Campus
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
University of Nebraska
Omaha, Nebraska, United States, 68198
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
10
Oregan Health & Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
11
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
12
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Federica Giordano, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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