Actively Recruiting
A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL)
Led by March Biosciences Inc · Updated on 2025-10-03
46
Participants Needed
12
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MB-105, a CAR T-cell therapy, in patients with CD5 Positive Relapsed/Refractory T-cell Lymphoma (r/r TCL). This Phase 2, open-label, multicenter study uses a Simon two-stage design to assess the safety and preliminary effectiveness of MB-105 in this specific lymphoma population. The study aims to better understand the response rates and safety profile of this investigational treatment. The study is divided into two stages. The first stage will enroll about 15 patients, starting with a safety run-in of 6 patients receiving a fixed dose of 50 million CAR-positive cells. An Independent Data Monitoring Committee (IDMC) will review safety data before continuing. If the dose is confirmed appropriate, 9 more patients will be enrolled to complete Stage 1. Stage 2 will then enroll approximately 31 additional patients, with ongoing safety and efficacy monitoring every 6 months. The study treatment consists of autologous T-cells engineered to express the CD5 CAR, delivered as MB-105. Participants will undergo screening, dosing, and follow-up visits up to at least 12 months after treatment. Assessments include monitoring adverse events, measuring tumor response using Lugano and Global criteria, and evaluating survival outcomes. Safety monitoring continues throughout the study, with long-term follow-up offered after study completion. The total participation duration includes treatment, up to one year of follow-up, and optional extended long-term monitoring.
CONDITIONS
Brief 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
- Diagnosed with relapsed or refractory T-cell lymphoma per WHO 2022 criteria
- For CTCL, failed at least 2 prior standard of care therapies
- For PTCL, failed at least 1 prior standard of care therapy; CD30+ patients should have received brentuximab vedotin
- Available tumor tissue or willing to undergo biopsy
- CD5 positivity with at least 50% expression confirmed by approved test
- Karnofsky performance score of 70% or higher
- Prior CAR T-cell therapy must be more than 60 days ago with no CAR persistence
- Measurable or detectable disease by specified criteria
- Prior hematopoietic stem cell transplant more than 60 days ago
- Adequate bone marrow function with specific blood count thresholds
- Adequate organ function including cardiac, pulmonary, renal, and liver criteria
- Negative pregnancy test for females of childbearing potential
- Use of effective contraception for 12 months after last dose for males and females of childbearing potential
You will not qualify if you...
- Diagnosis of Sezary syndrome
- Contraindications to leukapheresis
- Prior treatment with any CD5-targeted therapy
- Active HIV infection or chronic hepatitis B with detectable viral load
- Active hepatitis C infection with detectable viral load
- Active uncontrolled systemic infections requiring IV anti-infectives
- History of malignancy within 2 years except certain cured or indolent cancers
- History of hypersensitivity to murine protein products
- Active central nervous system lymphoma
- Significant acute or chronic graft versus host disease requiring systemic steroids
- Recent systemic immunosuppressive therapy for graft versus host disease
- Current systemic corticosteroid therapy above allowed doses without required washout
- Recent donor lymphocyte infusions
- Serious comorbidities affecting ability to participate or tolerate treatment
- History of autoimmune disorders except mild or well-controlled thyroid disease
- Participation in other interventional trials within 30 days prior to enrollment
- Prior bendamustine treatment without interim allogeneic stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to Day 30 after treatment for initial safety assessment; treatment continues for remaining patients after dose confirmation
Participants receive MB-105, a CAR T-cell therapy, at the recommended phase 2 dose. The first 6 patients will be treated and monitored for safety up to Day 30 before continuing enrollment. The treatment involves infusion of genetically modified autologous T-cells targeting CD5-positive T-cell lymphoma.
1 infusion visit and multiple follow-up visits up to Day 30
Duration - Up to 12 months
Participants are monitored for safety and efficacy up to Day 56 after treatment, including assessment of response per lymphoma criteria. Monitoring continues for up to 12 months after treatment to evaluate long-term outcomes.
Multiple visits including efficacy assessments up to Day 56 and periodic visits up to 12 months
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.
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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