CD123 Redirected T Cells for AML in Pediatric Subjects (NCT04678336) | Clinical Trial Compass
TerminatedPhase 1
CD123 Redirected T Cells for AML in Pediatric Subjects
Stopped: Administrative reasons
United States12 participantsStarted 2021-04-02
Plain-language summary
Phase 1 open-label study to evaluate the safety of intravenously administered, lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains in pediatric subjects with relapsed/refractory Acute Myeloid Leukemia (AML).
Who can participate
Age range1 Year – 29 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female patients ≥ 1 and ≤ 29 years of age at time of consent.
✓. AML in second or greater relapse, post-transplant relapse, or chemotherapy-refractory disease. Specifically:
✓. Second or greater relapse defined as flow cytometric confirmation of myeloid leukemia of at least 0.1% after second documented complete remission; OR
✓. Any detectable disease post-allogeneic transplant with flow cytometric confirmation (MRD) of myeloid leukemia of at least 0.1% (as confirmed by Hematologics); OR
✓. Refractory disease, defined as persistent bone marrow involvement with \>5% blasts after two courses of induction chemotherapy for patients at initial presentation or \>5% bone marrow blasts after one course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR.
✓. Subjects must have a suitable stem cell donor identified with projected ability to proceed to transplant within 6-8 weeks of CART123 infusion.
✕. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy
✕. Patients requiring chronic treatment with systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroids and immunosuppressant medications (including washout requirements prior to CAR T cell administration).
✕. Any uncontrolled active medical disorder that would preclude participation as outlined.