Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03217617 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

SCID-X1 Gene Therapy Via Intravenous Lentiviral (Ivlv-X1) Injection

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
See other at-risk trials from Shenzhen Geno-Immune Medical Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2028v9 Show 5 more changesShow less
    • Start date: Jun 30, 2024 to Jun 30, 2027
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Study completion pushed from Dec 31, 2027 to Dec 31, 2029
    • Study description expanded, about 66 words
    • Site details revised
  2. Study sites: 2 to 1v8
  3. Re-verified, no change to tracked fieldsv7
  4. Primary completion date: Dec 31, 2019 to Dec 31, 2026v6 Show 7 more changesShow less
    • Start date: Jul 15, 2017 to Jun 30, 2024
    • Study sites: 3 to 2
    • Study completion date: Dec 31, 2020 to Dec 31, 2027
    • Interventions: TYF-IL-2Rg gene-modified autologous stem cells (Biological) to Direct intravenous injection of ivlv-X1 lentiviral vector (Biological)
    • Eligibility criteria expanded, about 122 words
    • Study description expanded, about 1 word
    • Study title shortened, about 2 words
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Enrollment target: 30 to 10v4 Show 6 more changesShow less
    • Primary endpoints: 1 to 3
    • Interventions: Gene-modified autologous stem cells (Biological) to TYF-IL-2Rg gene-modified autologous stem cells (Biological)
    • Eligibility criteria shortened, about 129 words
    • Secondary endpoints shortened, about 12 words
    • Study description expanded, about 1 word
    • Study title expanded, about 1 word
  2. Enrollment target: 10 to 30v3 Show 5 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 2 to 3
    • Eligibility criteria shortened, about 41 words
    • Study description expanded, about 6 words
    • Study title revised
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv2
  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.
This is a Phase I/II gene therapy trial treating X-linked severe combined immunodeficiency (SCID-X1) using a self-inactivating lentiviral vector (ivlv-X1) to functionally correct the genetic defect. The primary objectives are to evaluate the safety and efficacy of the direct intravenous lentiviral gene transfer protocol.
Trial Details
NCT Number NCT03217617
Lead Sponsor Shenzhen Geno-Immune Medical Institute
Conditions
(from sponsor)		 SCID, X-Linked
Related terms X-Linked Combined Immunodeficiency Diseases
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov