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ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia

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

Record History

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  1. Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 9 entries
    • Study description revised
    • Site details revised
    • Eligibility criteria shortened, about 4 words
  2. Eligibility criteria revisedv13
  3. Re-verified, no change to tracked fieldsv12
  4. Study description expanded, about 1 wordv11
  5. Eligibility criteria expanded, about 11 wordsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria expanded, about 38 wordsv9
  2. Start date changed from estimate of Apr 1, 2025 to Apr 14, 2025v8
  3. Start date: Feb 1, 2025 to Apr 1, 2025v7
  4. Start date: Jan 1, 2025 to Feb 1, 2025v6
  5. Start date: Nov 1, 2024 to Jan 1, 2025v5
  6. Start date: Sep 1, 2024 to Nov 1, 2024
    • Eligibility criteria expanded, about 6 words
    v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 1, 2024 to Sep 1, 2024
    • Site details revised
    v3
  8. Start date: May 1, 2024 to Aug 1, 2024
    • Eligibility criteria expanded, about 5 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main goal of this study is to find out if the blood disorder called transfusion-dependent beta thalassemia can be safely treated by modifying blood stem cells. This is done by collecting blood stem cells from the subject, modifying those cells, adding a healthy beta globin gene, and then giving them back to the subject. It is hoped that these modified cells will decrease the need for blood transfusions. The gene modified blood stem cells are called CHOP-ALS20 ("study drug"). This experimental gene therapy has not been tried on human beings before and is not FDA approved.
Trial Details
NCT Number NCT06364774
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Beta-Thalassemia
Related terms beta-Thalassemia, Thalassemia
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov