Status:
RECRUITING
MB-105 in Patients With CD5 Positive T-cell Lymphoma
Lead Sponsor:
March Biosciences Inc
Conditions:
Lymphoma, T-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tw...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
February 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06534060
Start Date
February 15 2025
End Date
December 1 2029
Last Update
October 3 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of San Diego (UCSD)-Moores Cancer Center
San Diego, California, United States, 92037
2
SCRI - Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States, 92037
3
Moffitt Cancer Center Magnolia Campus
Tampa, Florida, United States, 33612
4
University of Iowa
Iowa City, Iowa, United States, 52242