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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of San Diego (UCSD)-Moores Cancer Center
RECRUITING
San Diego
Colorado
SCRI - Colorado Blood Cancer Institute (CBCI)
NOT_YET_RECRUITING
Denver
Florida
Moffitt Cancer Center Magnolia Campus
RECRUITING
Tampa
Iowa
University of Iowa
RECRUITING
Iowa City
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Nebraska
University of Nebraska
RECRUITING
Omaha
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Oregon
Oregan Health & Science University
NOT_YET_RECRUITING
Portland
Texas
Baylor College of Medicine
RECRUITING
Houston
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Federica Giordano, Ph.D.
clinicaltrials@march.bio
7138980838
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2029-12
Participants
Target number of participants: 46
Treatments
Other: Single arm
This is a single arm, two-stage, Phase 2, open-label, multicenter study.
Related Therapeutic Areas
Sponsors
Leads: March Biosciences Inc

This content was sourced from clinicaltrials.gov