- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03927261
Recruitment Status Recruiting
First Posted April 25, 2019
Last update posted September 23, 2020
This study is to determine the safety and best dose of PRGN-3006 T Cells
This is a single center, nonrandomized, investigator-initiated Phase 1/1b safety and tolerability study. The safety and tolerability of PRGN-3006 T cells will be assessed following intravenous administration of escalating doses in patients with relapsed or refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). This study will enroll in two phases: an initial dose escalation phase followed by a dose expansion phase.
|Experimental: Dose Escalation and Dose Expansion of PRGN-3006
Participants will be treated in dose escalation phase to identify the safety and maximum tolerated dose (MTD) of PRGN-3006.
Drug: PRGN-3006 T Cells
Participants will receive a single intravenous (IV) administration of PRGN-3006 T Cells, and will be monitored for safety in the clinic for at least 7 days following infusion, and for safety, efficacy and correlative endpoints up to 12 months following infusion.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Participants must be diagnosed with either relapsed or refractory AML or higher risk
- Absolute lymphocyte count ≥ 0.2 k/μL.
- 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) 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
- Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic
leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.
- Participants with extramedullary disease as their sole site of relapsed AML.
- 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 AML 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.
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: David A Sallman, MD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Nelli Bejanyan, MD Moffitt Cancer Center