A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Part of paid clinical trials in Los Angeles, California.

Sponsor
PureTech
Study ID
NCT05829226
Phase
PHASE1
Status
Completed

Conditions

  • AML, Adult Recurrent
  • MDS

Eligibility Criteria

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

Interventions

  • LYT-200 — DRUG
    monoclonal antibody (mAb), targeting galectin-9 protein
  • Venetoclax — DRUG
    Bcl-2 inhibitor
  • Azacitidine — DRUG
    Hypomethylating agent
  • Decitabine — DRUG
    Hypomethylating agent

Study Details

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk Myelodysplastic Syndrome (MDS)

Key Dates

Start date
Dec 12, 2022
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
101 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single agent dose escalation
    LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week.
  • Experimental: Combination agent dose escalation
    LYT-200 in relapsed/refractory AML or relapsed/refractory high-risk MDS, administered via IV infusion over 60 minutes every week, in combination with oral venetoclax Day 1, 100 mg, Day 2, 200mg, Day 3-28, 400 mg and/or azacitidine, 75 mg/m2 subcutaneously given for 7 days per cycle or decitabine 20 mg/m2 IV for 5 days per cycle.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and RP2D determination] [ Time Frame: approximately 1 year ]

Locations (9)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of California Irvine Medical CenterOrangeCalifornia92868-
Baptist Health South Florida-Miami Cancer InstituteMiamiFlorida02114-
Norton Healthcare-Norton Cancer InstituteLouisvilleKentucky40207-
Mass. General Hospital-HarvardBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Rhode Island HospitalProvidenceRhode Island02903-
Virginia Commonwealth University Medical CenterRichmondVirginia23219-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California Irvine Medical Center· Orange, CABaptist Health South Florida-Miami Cancer Institute· Miami, FLNorton Healthcare-Norton Cancer Institute· Louisville, KYMass. General Hospital-Harvard· Boston, MAKarmanos Cancer Institute· Detroit, MI

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