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Lymphoma, T-CellPhase 2NCT06534060

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

A Phase 2 study testing Genetic: MB-105 in people with Lymphoma, T-Cell, run by March Biosciences Inc at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, T-Cell
What is being tested?
Genetic: MB-105
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
12 sitesUnited States
Study dates
15 Feb 2025to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
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  • 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
  • Hemoglobin ≥ 8 g/dL (transfusion permitted)
  • Platelet count ≥ 75 000/μL (≥50 000/μL for patients with marrow involvement).
  • Organ function as follows:
  • Cardiac: left ventricular ejection fraction (LVEF) ≥ 50% by Echo or radionuclide scan.
  • Pulmonary: oxygen saturation ≥ 92% (room air).
  • Renal: calculated creatinine clearance > 30 mL/min.
  • Liver:
  • Total bilirubin < 1.5 x ULN (< 2 × upper limit of normal (ULN)) if liver involvement).
  • If no liver involvement and total bilirubin ≥1.5 x ≤ ULN, direct bilirubin < ULN (Gilbert syndrome)
  • Aspartate aminotransferase / alanine aminotransferase < 3 × ULN (5 x ULN if liver involvement).
  • Albumin > 2.5 g/dL.
  • For females of childbearing potential (defined as < 24 months of amenorrhea or not surgically sterile [absence of ovaries and/or uterus]), a negative serum pregnancy test must be documented at screening, and prior to lymphodepletion (conditioning).
  • For females of childbearing potential and males, a highly effective method of contraception together with a barrier method must be used from the start of lymphodepletion (conditioning) and for at least 12 months after the last dose of study agent.

Who cannot join

  • 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).
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  • 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.
  • Currently requiring systemic corticosteroid therapy (10 mg/day or less of prednisone or equivalent doses of other systemic steroids are allowed for control of non-exclusionary pre-existing conditions). A 2-week washout is required prior to leukapheresis and prior to lymphodepletion for patients on > 10 mg/day prednisone equivalent.
  • 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:
  • History of cardio- or cerebrovascular disease including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III-IV) within 6 months or cerebrovascular accident (CVA; stroke) within 12 months prior to informed consent.
  • History of central nervous system (CNS) disorder(s) such as an uncontrolled seizure disorder, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  • Any serious underlying medical or psychiatric condition deemed by the investigator and medical monitor to be exclusionary due to risk to the patient or to protocol compliance.
  • History of autoimmune disorders, including rheumatic diseases and thyroid disorders (though patients with a history of thyroid disease who have undergone successful therapy may be suitable). Exemptions for mild or limited disease may be granted after discussion between the Investigator and sponsor's medical monitor.
  • Participated in active treatment on other interventional research clinical trials < 30 days before enrollment (participation in follow-up permitted). Contact the medical monitor to discuss prior experimental agents targeting the T cell lineage and the appropriate washout period.
  • Received bendamustine prior to enrollment (unless received an allo-HSCT in the interim).

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Federica Giordano, Ph.D. contact

7138980838 ext. +1

clinicaltrials@march.bio

12 sites in 1 country

United States12 sites, 12 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Salvia Jain, MD, 857-392-4495, salvia.jain@mgh.harvard.edu

    Salvia Jain, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Caroline Babinec, 919-962-7426, Caroline_babinec@med.unc.edu

    UNCImmunotherapy@med.unc.edu

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Deepa Jagadeesh, MD

    Not yet recruiting

  • SCRI - Colorado Blood Cancer Institute (CBCI)

    Denver, Colorado, 92037

    Not yet recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Brandon Garner, 832-824-4594, bjgarner@texaschildrens.org

    Martha Arredondo, Martha.Arredondo@bcm.edu

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Christine Samuel, MSN, csamuel@mdanderson.org

    Swaminathan P. Iyer, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Gail Nelson, 319-678-7922, gail-nelson@uiowa.edu

    Eric Mou, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Steven Horwitz, MD

    Recruiting

  • University of Nebraska

    Omaha, Nebraska, 68198

    Julie Vose, MD

    Recruiting

  • Oregan Health & Science University

    Portland, Oregon, 97239

    Andy Chen, MD

    Not yet recruiting

  • University of San Diego (UCSD)-Moores Cancer Center

    San Diego, California, 92037

    Aaron Goodman, MD, a1goodman@health.ucsd.edu

    Krisma Cecilia Cecilia Montalvo, 858-822-5364, k1montalvo@health.ucsd.edu

    Recruiting

  • Moffitt Cancer Center Magnolia Campus

    Tampa, Florida, 33612

    Rebecca Delph, 813-745-0582, rebecca.delph@moffitt.org

    Alexandr Lazaryan, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL).

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.

Read the detailed description

The first stage of the Simon two-stage design will enroll approximately 15 evaluable patients. Once the first 6 patients are enrolled, have received one dose of MB-105 at the recommended phase 2 dose (RP2D), and completed at least up to Day 30 of the study, the Independent Data Monitoring Committee (IDMC) will perform a safety analysis. The IDMC will use this analysis to confirm that the RP2D selected for this Phase 2 study is the appropriate dose of MB-105 for further clinical evaluation. The IDMC will either recommend continuing the remainder of the study at the fixed dose of 50 million (5 x 107) Chimeric antigen receptor (CAR) positive cells or recommend other actions, which could include repeating the safety run-in with either a lower or higher dose. The IDMC will not recommend a MB-105 dose greater than those found safe in the phase 1 study. During the safety analysis period after the 6th patient is treated and awaiting data analysis, patients will continue to be screened but not dosed until the IDMC recommendation is made.

If the IDMC confirms the suggested RP2D is the appropriate dose for further clinical evaluation, the study will enroll an additional 9 patients to complete 15 total patients for Stage 1 to obtain a preliminary estimate of response rate per Lugano criteria for peripheral T-cell lymphoma (PTCL) and 2022 Global criteria for cutaneous cases (CTCL). At the end of Stage 1, defined as when the last patient enrolled completes study visits up to Day 56, including efficacy assessment, the IDMC will convene to review all available Stage 1 data and recommend continuation to Stage 2 or closure of enrollment.

Stage 2 will enroll approximately 31 patients, for a total of 46 patients in the study. During Stage 2 the IDMC will convene at least once every 6 months to review safety and efficacy on an ongoing basis. No formal interim analysis is planned after the end of Stage 1, but since this is an open-label study, interim data extracts may be performed to support abstract submissions, presentations, or regulatory discussions. The study will end once the last patient completes at least 12 months of follow-up and end of study (EOS) visit. After EOS, all patients will be asked to participate in a separate long term follow-up (LTFU) study.

Being tested
Genetic: MB-105
Keywords
MB-105-201
Medical subject headings
Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic: MB-105Biological

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

Study groups in NCT06534060
Study groupRoleWhat they receive
Single armOtherThis is a single arm, two-stage, Phase 2, open-label, multicenter study.
Receives: Biological: Genetic: MB-105

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence, severity, causal relationship of AEs

    Measured: 26 months

  2. 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.

    Measured: 26 months

Secondary outcomes (4)

  1. Duration of response (DOR)

    Duration of Response (DOR), defined as time from first observation of response to the time of disease progression or death, whichever comes first (per investigator and by central review).

    Measured: 26 months

  2. Progression-free survival (PFS)

    Progression-free survival (PFS), defined as time from administration of MB-105 to the time of disease progression or death, whichever comes first (per investigator and by central review).

    Measured: 26 months

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

    • All AEs from leukapheresis up to Day 30.
    • Related AEs from MB-105 infusion to Day 90 (i.e. excluding only AEs that are clearly an expected event from underlying condition or non-study related treatment).
    • SAEs and all-cause mortality from MB-105 infusion to EOS at Month 24.

    Measured: 26 months

  4. Overall survival (OS)

    Overall survival (OS), defined as time from administration of MB-105 to death.

    Measured: 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start15 Feb 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534060
Sponsor's protocol ID
MB-105-201
Status last verified
Sep 2025
First submitted
25 Jul 2024
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Genetic: MB-105 in people with Lymphoma, T-Cell, run by March Biosciences Inc at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Federica Giordano, Ph.D. (7138980838 ext. +1, clinicaltrials@march.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: 26 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06534060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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