New treatment combining stem cell transplant and CAR T-cell therapy for acute leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a novel treatment for acute myeloid leukemia (AML) by combining a modified stem cell transplant with engineered CAR T-cells that target AML cells. The approach involves infusing blood-forming stem cells from a healthy donor, followed by CAR T-cells that are designed to attack leukemia cells while avoiding damage to the transplanted healthy cells. This innovative method seeks to enhance the effectiveness of treatment for patients with refractory or relapsed AML who have limited options available.

Why it matters

Who can join: the full rules

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 month at the time of enrollment.
3. Subjects must have a suitable stem cell donor.
4. Satisfactory organ function

   1. Creatinine clearance \> 40 ml/min
   2. ALT/AST must be ≤ 5x upper limit of normal unless related to disease and \< 20 x upper limit of normal if related to disease
   3. Direct bilirubin \< 2.0 mg/dl, unless subject has Gilbert's syndrome (≤ 3.0 mg/dL)
5. Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA
6. DLCO \> 45% predicted
7. ECOG performance status 0-1
8. Written informed consent is given
9. Subjects of reproductive potential must agree to use acceptable birth control methods

Exclusion Criteria:

1. Pregnant or lactating (nursing) women
2. Active hepatitis B or hepatitis C or HIV infection
3. Concurrent use of systemic steroids or immunosuppressant medications
4. Any uncontrolled active medical disorder that would preclude participation as outlined
5. Subjects with signs or symptoms indicative of CNS involvement.
6. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
7. Class III/IV cardiovascular disability according to New York Heart Association Classification
8. Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management, within 2 weeks of the screening/enrollment visit.

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Noelle Frey, MD — University of Pennsylvania
• Study coordinator: Abramson Cancer Center Clinical Trials Service
• Email: PMCancerResearch@pennmedicine.upenn.edu
• Phone: 215-349-8245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.