RECRUITING

CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML

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Conditions

Leukemia, Myeloid, Acute

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Study of Lentivirally Transduced T Cells Engineered to Contain Anti-CD33 Linked to TCRζ And 4-1BB Signaling Domains In Combination With CD33KO-HSPC In Subjects With Refractory Or Relapsed Acute Myeloid Leukemia

Quick Facts

Study Start:2024-02-23
Study Completion:2044-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05945849

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female 18 years of age or older
  2. 2. Subjects with AML unlikely to be cured with currently available therapies
  3. 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:
  4. 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:
  5. 3. Subjects with relapsed disease after prior transplant must be off systemic immunosuppression for at least 1 month at the time of enrollment.
  6. 3. Subjects must have a suitable stem cell donor.
  7. 4. Satisfactory organ function
  8. 1. Creatinine clearance \> 40 ml/min
  9. 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
  10. 3. Direct bilirubin \< 2.0 mg/dl, unless subject has Gilbert's syndrome (≤ 3.0 mg/dL)
  11. 5. Left ventricular ejection fraction ≥ 40% as confirmed by echocardiogram or MUGA
  12. 6. DLCO \> 45% predicted
  13. 7. ECOG performance status 0-1
  14. 8. Written informed consent is given
  15. 9. Subjects of reproductive potential must agree to use acceptable birth control methods
  1. 1. Pregnant or lactating (nursing) women
  2. 2. Active hepatitis B or hepatitis C or HIV infection
  3. 3. Concurrent use of systemic steroids or immunosuppressant medications
  4. 4. Any uncontrolled active medical disorder that would preclude participation as outlined
  5. 5. Subjects with signs or symptoms indicative of CNS involvement.
  6. 6. Known history of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
  7. 7. Class III/IV cardiovascular disability according to New York Heart Association Classification
  8. 8. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
  9. 9. Subjects with clinically apparent arrhythmia, or arrhythmias that are not stable on medical management, within 2 weeks of the screening/enrollment visit.

Contacts and Locations

Study Contact

Abramson Cancer Center Clinical Trials Service
CONTACT
855-216-0098
PennCancerTrials@careboxhealth.com

Principal Investigator

Noelle Frey, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Noelle Frey, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-23
Study Completion Date2044-02-23

Study Record Updates

Study Start Date2024-02-23
Study Completion Date2044-02-23

Terms related to this study

Additional Relevant MeSH Terms

  • Leukemia, Myeloid, Acute