Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

Part of paid clinical trials in Duarte, California.

Sponsor
SystImmune Inc.
Study ID
NCT06714591
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-M11D1 — DRUG
    The study includes 2 parts: Part 1 Dose escalation and Dose Finding

Study Details

The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.

Key Dates

Start date
Dec 19, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

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

Arms

  • Experimental: Experimental: Cohort A BL-M11D1 administered Days 1, 8 and 15 in 28-day cycle
    Cohort A: BL-M11D1 will be administered on Days 1, 8 and 15 by intravenous infusion every 28 days.
  • Experimental: Experimental: Cohort B BL-M11D1 administered Days 1, 4 7 or 8 in 28-day cycle
    Cohort B: BL-M11D1 will be administered on Days 1,4, 7 or 8 by intravenous infusion every 28 days.

Primary Outcome Measure

Participants with dose-limiting toxicities [ Time Frame: 1 Year ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Manjyot Nanhwan
[email protected]
Anthony Stein, MD (PRINCIPAL_INVESTIGATOR)
UCLA Ronald Reagan Medical CenterLos AngelesCalifornia90095
Bruck Habtemarian
[email protected]
Gary Schiller, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Anschutz Medical CampusAuroraColorado80045
Francesca Dino
[email protected]
Christine McMahon (PRINCIPAL_INVESTIGATOR)
Yale Cancer Center, Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06511
Farah Fasihuddin
[email protected]
Amer Zeidan, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Lisa Nardelli
[email protected]
David Sallman, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Samara Francis
[email protected]
Jessica Altman (PRINCIPAL_INVESTIGATOR)
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287
Sarah H Bookman
[email protected]
Ivana Gojo (PRINCIPAL_INVESTIGATOR)
START Midwest/The Cancer and Hematology CenterGrand RapidsMichigan49546
Audrey Split
[email protected]
616-389-1670
Andrew Sochacki, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center-HackensackHackensackNew Jersey07601
Parita Patel
[email protected]
James McCloskey (PRINCIPAL_INVESTIGATOR)
Oncology Hematology Care Clinical Trials, LLCCincinnatiOhio45236
Crystal Daffner
[email protected]
Kruti Patel, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Meaghan Colvin
[email protected]
Uma Borate, MD (PRINCIPAL_INVESTIGATOR)
WVCI Oncology Associates of OregonEugeneOregon24224
Jeanne Schaffer
[email protected]
Luke Fletcher, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Curtis Lachowiez (PRINCIPAL_INVESTIGATOR)
Temple Health Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Allandria Straker-Edwards
[email protected]
Sasha A Vartanov (PRINCIPAL_INVESTIGATOR)
SCRI -TriStar BMTNashvilleTennessee37203
Clemence Walker
[email protected]
Stephen Strickland, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Dono Tippett
[email protected]
Courtney DiNardo, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Carolyn Grausgruber
[email protected]
Mitul Gandhi, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Mary Elizabeth Percival, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUCLA Ronald Reagan Medical Center· Los Angeles, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COYale Cancer Center, Smilow Cancer Hospital at Yale New Haven· New Haven, CTMoffitt Cancer Center· Tampa, FLNorthwestern Memorial Hospital· Chicago, IL

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