Status:
COMPLETED
Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord Blood Transplantation
Lead Sponsor:
Angiocrine Bioscience
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) under...
Eligibility Criteria
Inclusion
- Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
- Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse
- Complete second remission (CR2).
- No documented myelofibrosis at screening marrow biopsy
- Acute lymphoblastic leukemia (ALL):
- Complete first remission (CR1) at high risk for relapse
- Complete second remission (CR2).
- Other acute leukemias that are of ambiguous lineage or of other types
- Any acute leukemia with marrow aplasia or without adequate count recovery.
- Myelodysplastic Syndrome (MDS)
- Karnofsky score \> 70 %.
- Calculated creatinine clearance \> 60 ml/min.
- Bilirubin \< 1.5 mg/dL, ALT \< 3 x upper limit of normal
- Pulmonary function (FVC, FEV1 and corrected DLCO) \> 50% predicted.
- Left ventricular ejection fraction \> 50%.
- Albumin \> 3.0 g/dL.
- Negative antiviral serology:
- Negative human immunodeficiency virus (HIV) antibody.
- Negative human T-lymphotropic virus (HTLV)-1 and 2 antibodies.
- Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
- Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
- For female subjects of childbearing potential:
- A negative serum pregnancy test
- Willing to use contraception throughout the study period.
- Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
- Two appropriate CB units identified for the subject.
- In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
- Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- Evidence of a signed informed written consent
Exclusion
- Pregnancy or breastfeeding.
- Current active, uncontrolled bacterial, viral, or fungal infection
- Prior allogeneic or autologous HCT at any time.
- Active malignancy other than the one for which AB-110 transplant is being performed within 12 months of enrollment.
- Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
- Have evidence of recipient donor specific anti-HLA antibodies.
- Active central nervous system (CNS) disease at time of screening.
- Documented allergy to DMSO, mouse or bovine proteins, or iron.
- Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
- Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03483324
Start Date
April 24 2018
End Date
January 31 2022
Last Update
May 31 2022
Active Locations (3)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of Colorado Cancer Center University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065