CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML
ConditionLeukemia, Myeloid, Acute
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
The purpose of this study is to provide a new type of treatment for AML. This treatment combines a new type of stem cell transplant along with treatment using chimeric antigen receptor (CAR) T cells that have been engineered to recognize and attack your AML cells.
The first treatment is a modified stem cell transplant, using blood-forming stem cells donated from a healthy donor. From the same donor, we will also make CAR T-cells, which are leukemia fighting cells, which will be given to the patient via an infusion into the vein after the transplanted stem cells have started to grow healthy blood cells. The modification of the stem cell transplant means that the healthy bone marrow cells will be "invisible" to the CAR T-cells that are trying to kill the leukemia cells.
Eligibility criteria
Qualifiers
Male or female 18 years of age or older
Subjects with AML unlikely to be cured with currently available therapies
Subjects with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment.
Subjects must have a suitable stem cell donor.
Disqualifiers
Pregnant or lactating (nursing) women
Active hepatitis B or hepatitis C or HIV infection
Concurrent use of systemic steroids or immunosuppressant medications
Any uncontrolled active medical disorder that would preclude participation as outlined
Trial design
Treatments tested in this trial
- CD33KO-HSPC; CART33
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov