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NCT03971799 · ClinicalTrials.gov registry record · Phase 1
Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study of Acute Myelogenous Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.
- Active
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 6
- Study locations
NCT03971799: Active Phase 1 study of Acute Myelogenous Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.
NCT03971799 is a Phase 1 study of Acute Myelogenous Leukemia that is active but no longer recruiting, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 52 participants, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (63% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03971799, a Phase 1 study of Acute Myelogenous Leukemia, is active but no longer recruiting, sponsored by Center for International Blood and Marrow Transplant Research.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determine the maximum tolerated dose of CD33CART cells using a 3+3 trial design, with dose-escalation for autologous products separated from dose-escalation for an allogeneic arm. Phase 2 is an expansion phase designed to evaluate the rate of response to CD33CART.
Primary Outcome
To determine the maximum tolerated dose of lentivirally-transduced autologous CD33-redirected CAR-T cells (CD33CART) in children and young adults with relapsed/refractory AML
Conditions Studied
Interventions
- BIOLOGICAL CD33CART autologous
- BIOLOGICAL CD33CART allogeneic
Study Locations (6)
California
- Children's Hospital of Los Angeles - Los Angeles
Colorado
- Children's Hospital of Colorado - Aurora
Maryland
- National Cancer Institute - NIH - Bethesda
Massachusetts
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Washington
- Seattle Children's Hospital/Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2039-12 |
| Phase | Phase 1 |
What the registry record for NCT03971799 still lists
NCT03971799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 139-participant average among 38 other Acute Myelogenous Leukemia trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Acute Myelogenous Leukemia appearing as the primary indexed condition, and to 2 interventions - of which CD33CART autologous is the first listed.
NCT03971799 lists 6 locations in 6 states (California, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT03971799 about?
NCT03971799 is a clinical study titled "Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia". This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determ...
What is the current status of trial NCT03971799?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-01-08. Estimated completion is 2039-12.
What conditions does trial NCT03971799 study?
This clinical trial studies the following conditions: Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT03971799?
The interventions under investigation include: CD33CART autologous (BIOLOGICAL), CD33CART allogeneic (BIOLOGICAL).
Who is sponsoring clinical trial NCT03971799?
This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03971799 being conducted?
This trial has 6 study locations across California, Colorado, Maryland, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03971799's enrollment target sits among peer trials
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