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New treatment option for Lymphoma, T-Cell
Official title MB-105 in Patients With CD5 Positive T-cell Lymphoma
ClinicalTrials.gov ID: NCT06534060
What this study is testing
What is Genetic: MB-105?
Genetic: MB-105 is an investigational medicine, being studied as a potential treatment for lymphoma, t-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Sezary syndrome. For other tumor types, if there is a suspicion of significant circulating disease at time of leukapheresis, discuss eligibility with...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Participated in active treatment on other treatment research clinical trials \< 30 days before enrollment (participation in follow-up permitted). Contact the medical monitor to discuss prior experimental agents...
- Received bendamustine prior to enrollment (unless received an allo-HSCT in the interim).
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Denver, Colorado, United States
- Tampa, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Denver, Colorado, United States; Tampa, Florida, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.