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 — BIOLOGICAL
    MB-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 arm
    This 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

Locations (12)

FacilityCityStateZIPSite coordinators
University of San Diego (UCSD)-Moores Cancer CenterSan DiegoCalifornia92037
Aaron Goodman, MD
Krisma Cecilia Cecilia Montalvo
858-822-5364
Aaron Goodman, MD (PRINCIPAL_INVESTIGATOR)
SCRI - Colorado Blood Cancer Institute (CBCI)DenverColorado92037-
Moffitt Cancer Center Magnolia CampusTampaFlorida33612
Rebecca Delph
813-745-0582
Alexandr Lazaryan, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Gail Nelson
319-678-7922
Eric Mou, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Salvia Jain, MD
857-392-4495
Salvia Jain, MD (PRINCIPAL_INVESTIGATOR)
University of NebraskaOmahaNebraska68198
Julie Vose, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Steven Horwitz, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Caroline Babinec
919-962-7426
Anne Beaven, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Deepa Jagadeesh, MD (PRINCIPAL_INVESTIGATOR)
Oregan Health & Science UniversityPortlandOregon97239
Andy Chen, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Brandon Garner
832-824-4594
Martha Arredondo
LaQuisa Hill, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Christine Samuel, MSN
Swaminathan P. Iyer, MD (PRINCIPAL_INVESTIGATOR)

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