NCT06534060 · March Biosciences Inc
MB-105 in Patients With CD5 Positive T-cell Lymphoma
What this study is about
This is a single treatment group$1, two-stage, Phase 2, where both patients and doctors know the treatment given, conducted at multiple hospitals 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Genetic: MB-105
MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.
Primary outcome measures
Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 26 months
Incidence, severity, causal relationship of AEs
Objective response rate (ORR)
Time frame: 26 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥ 18 years of age. 2. Patients with r/r TCL per WHO 2022 criteria. 1. r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy. 2. r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin. 3. Has available tumor tissue or is willing to undergo a biopsy procedure. 4. 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%. 5. Karnofsky performance score ≥ 70% or higher. 6. Prior CAR T-cell therapy must have occurred \> 60 days prior to study enrollment and must have no evidence of CAR persistence. 7. Measurable or detectable disease 1. PTCL per Lugano criteria 2. CTCL per Global (ISCL/EORTC/USCCL) criteria. 8. Prior autologous or allogenic hematopoietic stem cell transplant
Where
- San Diego, California
- Denver, Colorado
- Tampa, Florida
- Iowa City, Iowa
- Boston, Massachusetts
- Omaha, Nebraska
- New York, New York
- Chapel Hill, North Carolina
- Cleveland, Ohio
- Portland, Oregon
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations