A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL).
March Biosciences Inc
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Patients with r/r TCL per WHO 2022 criteria. 1. r/r CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy. 2. r/r PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin. 3. Has available tumor tissue or is willing to undergo a biopsy procedure. 4. 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 patie…
Interventions
- BiologicalGenetic: MB-105
MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.
Locations (12)
- University of San Diego (UCSD)-Moores Cancer CenterSan Diego, California
- SCRI - Colorado Blood Cancer Institute (CBCI)Denver, Colorado
- Moffitt Cancer Center Magnolia CampusTampa, Florida
- University of IowaIowa City, Iowa
- Massachusetts General HospitalBoston, Massachusetts
- University of NebraskaOmaha, Nebraska