CART123 Cells With or Without Ruxolitinib in Relapsed/Refractory Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-29
SponsorStephan Grupp MD PhD
About this trial
This study is designed to evaluate the safety and effectiveness of CART123 cells either alone or when combined with ruxolitinib in pediatric and young adult subjects with relapsed or refractory AML. Subjects will be enrolled into one of two treatment cohorts: subjects who will receive CART123 alone (Cohort A) or subjects who will receive CART123 in combination with ruxolitinib (Cohort B).
Eligibility criteria
Qualifiers
1. Age at time of consent: Cohort A: 0-29 years. Cohort B: 1-29 years (Note: the first subject at each dose level of Cohort B must be ≥12 years old)
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 of myeloid leukemia of at least 0.1%; OR
Refractory disease, defined as: Persistent bone marrow involvement with >5% blasts after two courses of induction chemotherapy for patients at initial presentation, >5% bone marrow blasts after one course of induction chemotherapy for patients who have relapsed after previously achieving a CR, and >5% bone marrow blasts after one course of AML-directed chemotherapy for those with myeloid lineage switch.
Disqualifiers
1. Active hepatitis B or active hepatitis C
2. HIV infection
3. Active acute or chronic GVHD requiring systemic therapy
4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
Trial design
Treatments tested in this trial
- Anti-CD123 LV redirected T cells (CART123)
- Ruxolitinib (JAKAVI®)
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stephan Grupp MD PhD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov