OncoMatch/Clinical Trials/NCT06534060
MB-105 in Patients With CD5 Positive T-cell Lymphoma
Is NCT06534060 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Genetic: MB-105 for lymphoma, t-cell.
Treatment: Genetic: MB-105 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD5 positivity (≥ 50% expression by approved diagnostic test or LDT) (≥ 50%)
CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT. CD5 positivity is currently defined as having ≥ 50% CD5 expression.
Prior therapy
Must have received: standard of care therapy — CTCL: ≥ 2 prior lines; PTCL: ≥ 1 prior line
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.
Must have received: antibody-drug conjugate (brentuximab vedotin) — CD30+ disease
patients with CD30+ disease should have received brentuximab vedotin
Cannot have received: CD5-targeted therapy
Prior treatment with any CD5-targeted therapy
Cannot have received: bendamustine (bendamustine)
Exception: unless received an allo-HSCT in the interim
Received bendamustine prior to enrollment (unless received an allo-HSCT in the interim)
Lab requirements
Blood counts
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)
Kidney function
calculated creatinine clearance > 30 mL/min
Liver function
Total bilirubin < 1.5 x ULN (< 2 × ULN if liver involvement); if no liver involvement and total bilirubin ≥1.5 x ≤ ULN, direct bilirubin < ULN (Gilbert syndrome); AST/ALT < 3 × ULN (5 x ULN if liver involvement); albumin > 2.5 g/dL.
Cardiac function
LVEF ≥ 50% by Echo or radionuclide scan
Adequate bone marrow function defined as: 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). Cardiac: 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 × ULN if liver involvement); if no liver involvement and total bilirubin ≥1.5 x ≤ ULN, direct bilirubin < ULN (Gilbert syndrome); AST/ALT < 3 × ULN (5 x ULN if liver involvement); albumin > 2.5 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of San Diego (UCSD)-Moores Cancer Center · San Diego, California
- SCRI - Colorado Blood Cancer Institute (CBCI) · Denver, Colorado
- Moffitt Cancer Center Magnolia Campus · Tampa, Florida
- University of Iowa · Iowa City, Iowa
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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