CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML
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,
| Condition(s) | Leukemia, Myeloid, Acute |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Male or female 18 years of age or older 2. Subjects with AML unlikely to be cured with currently available therapies 1. AML that has not achieved a complete remission or morphologic leukemia free state by ELN criteria; partial remission or refractory disease (including primary refractory) are eligible; OR: 2. AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note: morphologic relapse is not required; persistent/recurrent disease-associated molecular, phenotypic or cytogenetic abnormalities (measurable residual disease, MRD) at any time after allogeneic HCT is eligible; OR: 3. Subjects with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 mo |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Pennsylvania |
| Locations | Philadelphia, Pennsylvania, United States |
| Start date | 2024-02-23 |
| NCT ID | NCT05945849 |
| Official listing | https://clinicaltrials.gov/study/NCT05945849 |