Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06045910 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Feb 2028 to Dec 21, 2029 Start date: Jan 19, 2024 to Feb 7, 2024v7 Show 1 more changeShow less
    • Start date: Jan 19, 2024 to Feb 7, 2024
  2. Primary endpoints revised (7) Enrollment target: 72 to 84 · Primary and study completion dates: Dec 2027 to Feb 2028 · Eligibility criteria expanded, about 313 words · 1 morev6 Show 4 more changesShow less
    • Enrollment target: 72 to 84
    • Primary and study completion dates: Dec 2027 to Feb 2028
    • Eligibility criteria expanded, about 313 words
    • Secondary endpoints revised (9)

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 17 words Site details revised at 6 of 7 sitesv5 Show 1 more changeShow less
    • Site details revised at 6 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Jan 2024 to Jan 19, 2024v4
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 2023 to Jan 2024 · Study sites: 6 to 7v3 Show 2 more changesShow less
    • Start date: Nov 2023 to Jan 2024
    • Study sites: 6 to 7
  6. Start date: Sep 2023 to Nov 2023v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cancer Research UK
15 trials monitored
See 2 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
Follicular Lymphoma
313 trials monitored
See 26 trials at risk
and 1 more disease
This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in participants with B-cell malignancies post CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 and timing of administration will be evaluated in Phase I in order to define a recommended dosing level and time of administration for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.
Trial Details
NCT Number NCT06045910
Lead Sponsor Cancer Research UK
Collaborators: Aleta BioTherapeutics
Conditions Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Large B-cell Lymphoma
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov