MB-105 in Patients With CD5 Positive T-cell Lymphoma
Part of paid clinical trials in San Diego, California.
- Sponsor
- March Biosciences Inc
- Study ID
- NCT06534060
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Lymphoma, T-Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Genetic: MB-105 — BIOLOGICALMB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.
Study Details
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.
Key Dates
- Start date
- Feb 15, 2025
- Status verified
- Sep 2025
- Primary completion
- Feb 29, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 46 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Single armThis is a single arm, two-stage, Phase 2, open-label, multicenter study.
Primary Outcome Measure
Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 26 months ]
Central Contacts
- Federica Giordano, Ph.D.7138980838
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of San Diego (UCSD)-Moores Cancer Center | San Diego | California | 92037 | Aaron Goodman, MD Aaron Goodman, MD (PRINCIPAL_INVESTIGATOR) |
| SCRI - Colorado Blood Cancer Institute (CBCI) | Denver | Colorado | 92037 | - |
| Moffitt Cancer Center Magnolia Campus | Tampa | Florida | 33612 | Alexandr Lazaryan, MD (PRINCIPAL_INVESTIGATOR) |
| University of Iowa | Iowa City | Iowa | 52242 | Eric Mou, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Salvia Jain, MD (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska | Omaha | Nebraska | 68198 | Julie Vose, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Steven Horwitz, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Anne Beaven, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Deepa Jagadeesh, MD (PRINCIPAL_INVESTIGATOR) |
| Oregan Health & Science University | Portland | Oregon | 97239 | Andy Chen, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor College of Medicine | Houston | Texas | 77030 | Martha Arredondo LaQuisa Hill, MD (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Christine Samuel, MSN Swaminathan P. Iyer, MD (PRINCIPAL_INVESTIGATOR) |
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