BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS

Part of paid clinical trials in Duarte, California.

Sponsor
BlueSphere Bio, Inc
Study ID
NCT06704152
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • ALL, Recurrent, Adult
  • AML, Adult Recurrent
  • MDS

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SOC + BSB-1001 Dose Escalation Cohort — DRUG
    Patients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic stem cell transplant (HCT).
  • SOC+BSB-1001 Expansion Dose — DRUG
    Patients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic cell transplant (HCT).

Study Details

The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS). It will evaluate the safety of BSB-1001 and also determine whether it works to prevent relapse of your cancer.

Key Dates

Start date
Feb 4, 2025
Status verified
Aug 2025
Primary completion
Feb 28, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohorts
    AML, ALL and MDS HLA-A\*02:01 and HA-1-positive (H/H or H/R) patients with an identified HLA-matched, HA-1-negative (R/R) donor will be dosed in dose escalation cohorts
  • Experimental: BSB-1001 Expansion Dose
    Once the maximum tolerated dose (MTD) or promising dose is reached additional AML HLA-A\*02:01 and HA-1-positive (H/H or H/R) patients with an identified HLA-matched, HA-1-negative (R/R) donor will be enrolled in the expansion cohort.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs), including SAEs, GVHD and dose-limiting toxicities [ Time Frame: 365 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Moffitt Cancer CenterTampaFlorida33612-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Washington University at St LouisSt LouisMissouri63110-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAMoffitt Cancer Center· Tampa, FLUniversity of Michigan· Ann Arbor, MIUniversity of Minnesota· Minneapolis, MNWashington University at St Louis· St Louis, MOThe Ohio State University· Columbus, OH

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