PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS


About this study

The purpose of this study is to determine the safety and best dose of PRGN-3006 T Cells to treat relapsed/refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Participants must be diagnosed with either relapsed or refractory AML (including
extramedullary disease) or higher risk MDS/CMML.

- Absolute lymphocyte count ≥ 0.2 k/?L.

- Karnofsky performance status score ≥60%.

- Life expectancy ≥ 12 weeks from the time of enrollment.

- Pretreatment calculated or measured creatinine clearance (absolute value) of ≥ 40
mL/minute or Cr > 2x upper limit of normal (ULN).

- Serum bilirubin ≤ 2.0 mg/dL or total bilirubin ≤ 3.0 x IULN with direct bilirubin
within normal range in participants with well documented Gilbert's syndrome or
hemolysis or who require regular blood transfusions

- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) < 3.0 x IULN.

- Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan
(MUGA) > 45%.

- Participant does not require supplemental oxygen or mechanical ventilation AND has an
oxygen saturation by pulse oximetry of ≥ 92% or higher on room air.

- Negative serum pregnancy test. Note: Women of child-bearing potential and men must
agree to use adequate contraception prior to study entry and for at least 1 year
following study treatment (T cell infusion); should a woman participant or female
partner of a male participant become pregnant or suspect that she is pregnant while
participating on the trial, she should inform her treating physician immediately.

- Participant has a matched bone marrow donor and is otherwise able to receive a bone
marrow transplant (dose escalation part only)

- Participants who have undergone allo-SCT are eligible if they are at least 3 months
post SCT, have relapsed AML/MDS as defined above, are not on treatment or prophylaxis
for GVHD for at least 6 weeks before administration of CAR T cells, and have no active

- All participants must have the ability to understand and willingness to sign a written
informed consent.

Exclusion Criteria:

- Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic
leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.

- Known central nervous system (CNS) leukemic involvement that is refractory to
intrathecal chemotherapy and/or cranio-spinal radiation; participants with a history
of CNS disease that have been effectively treated to complete remission ( i.e. no
blasts in cerebrospinal fluid [CSF] by cytology and flow cytometry) will be eligible.

- Prior treatment with investigational CAR T therapy for any disease.

- Participants enrolled in another investigational therapy protocol for their disease
within 14 days or 5 half-lives of enrollment, whichever is shorter.

- Ongoing uncontrolled serious infection, symptomatic congestive heart failure, unstable
angina pectoris, uncontrolled cardiac arrhythmia, poorly controlled pulmonary disease
or psychiatric illness/social situations that would limit compliance with study

- Human immunodeficiency virus (HIV) seropositivity, or active hepatitis B or C
infection based on testing performed within 28 days of enrollment.

- Participants requiring agents other than hydroxyurea to control blast counts within 14
days of study enrollment.

- Participants with presence of other active malignancy within 1 year of study entry;

- Participants with adequately resected basal or squamous cell carcinoma of the skin, or
adequately resected carcinoma in situ (e.g. cervix) may enroll irrespective of the
time of diagnosis.

- Pregnant and lactating women are excluded from this study

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to cetuximab (anti-EGFR).

- Active autoimmune disease requiring systemic immunosuppressive therapy (i.e. >10mg of
prednisone daily or equivalent).

- Participant, who in the opinion of the investigator, may not be able to comply with
the safety monitoring requirements of the study.

Eligibility last updated 6/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hassan Alkhateeb, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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