Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Xencor, Inc.
With
ICON Clinical Research
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of 1 of the following diseases:
* Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
* B-cell ALL
* BPDCN
* CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
Patients with relapsed or refractory disease with no available standard therapy
ECOG performance status 0-2
Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation
Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045
Male patients must agree to use highly effective contraception, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of XmAb14045
Able and willing to complete the entire study
You may not be if
Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy
Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement)
Known uncontrolled central nervous system involvement by malignant disease
Absolute blast count ≥10,000/mm3 or symptoms of leukostasis
Diagnosis of promyelocytic leukemia
Aspartate aminotransferase or alanine aminotransferase at screening \>3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement
Bilirubin \>1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome
Serum creatinine \>2.0 x ULN, or estimated creatinine clearance \<40mL/min
Active heart failure or New York Heart Association Class III or IV or Objective Assessment C or D
History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures, or completion
Evidence of any active, uncontrolled bacterial, viral, parasitic, or systemic fungal infections within 1 week of first dose of study drug
Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine
Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the Investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study
Clareo Health | PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
