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Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from Gilead Sciences

Record History

  1. Primary endpoint(s) modified Sponsor changed: Arcellx, Inc. to Kite, A Gilead Company · Interventions modified · Eligibility criteria expanded, about 49 words · 4 more Show 7 more changesShow less
    • Sponsor changed: Arcellx, Inc. to Kite, A Gilead Company
    • Interventions modified
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 25 words
    • Collaborators expanded, about 2 words
    • Study title expanded, about 1 word
  2. Primary completion date: Sep 30, 2025 to Oct 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Nov 17, 2025 to Oct 2026 · Site details revised at 5 of 5 sites · 1 morev8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Nov 17, 2025 to Oct 2026
    • Site details revised at 5 of 5 sites
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 59 wordsv7 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 5 sitesv6
  5. Study sites: 4 to 5v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Study sites: 5 to 4 Study description shortened, about 1 wordv3 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 0 to 5 · Start date changed from estimate of Sep 30, 2022 to Nov 28, 2022 · 5 morev2 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 5
    • Start date changed from estimate of Sep 30, 2022 to Nov 28, 2022
    • Interventions: ARC-T (Biological), SPRX002 (Biological) to ARC-T Cells (Biological), SPRX002 (Biological)
    • Eligibility criteria expanded, about 934 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 162 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The goal of the Arm 1 study is to assess the safety, tolerability, PK, and PD of the study drugs, Antigen Receptor Complex T (ARC-T) cells and CD123-specific soluble protein antigen-receptor X-linker (SPRX002), in participants with relapsed or refractory AML or MDS. The primary objective of this study is to assess the safety profile (including any dose-limiting toxicity (DLT)), to determine recommended Phase 2 dose (RP2D) of the investigational agents when infused in participants with relapsed and refractory AML or MDS.
Trial Details
NCT Number NCT05457010
Lead Sponsor Kite, A Gilead Company
Collaborators: Arcellx, Inc.
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov