Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

Hodgkin Lymphoma Clinical Trial

Official title:

A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925935
• Other study ID #: AB-205-001
• Status: Completed
• Phase: Phase 1
• Start date: May 7, 2019
• Est. completion date: November 8, 2021

Study information

• Verified date: March 2022
• Source: Angiocrine Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 8, 2021
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

• Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:

• carmustine, etoposide, cytarabine, melphalan (BEAM)

• cyclophosphamide, carmustine, etoposide (CBV)

• thiotepa, busulphan, cyclophosphamide (TBC)

• additional myeloablative chemotherapy-based conditioning regimens may be permitted with the approval of the medical monitor

• Adjunct radiation therapy to HDT will be allowed.

• Adequate organ function is required, defined as follows:

• Serum bilirubin = 2 mg/dL, unless benign congenital hyperbilirubinemia

• AST, ALT, and alkaline phosphatase < 3 times the upper limit of normal

• Creatinine clearance = 40 ml/min (calculated by Cockcroft Gault)

• LVEF = 45% by MUGA or resting echocardiogram

• Pulmonary function (FEV1 and corrected DLCO) = 45% predicted

• Adequate performance status ECOG =1

• For female subjects of childbearing potential:

• A negative serum or urine pregnancy test at screening.

• Subject must be willing to use a recommended method of contraception from the start of the screening period and throughout the study period.

• For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:

• Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of conditioning therapy for at least 1 year after completion and discussion with a treating physician.

• Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.

• Ability to provide written informed consent.

EXCLUSION CRITERIA

• History of prior ASCT.

• Active malignancy other than the one for which the subject is undergoing HDT-ASCT. (Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible.)

• Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics.

• Active Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency Syndrome (AIDS).

• Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days or longer after chemotherapy treatment discontinuation if required by prescribing information for chemotherapy agents received during the study.

• Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO.

• 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.

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Non-hodgkin Lymphoma

Intervention

Biological:
• AB-205
Engineered human umbilical vein endothelial cells

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson	Houston	Texas
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	UC San Diego Moores Cancer Center	San Diego	California
United States	The University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Angiocrine Bioscience	California Institute for Regenerative Medicine (CIRM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events grade = 3 as assessed by CTCAEv5		24 hours
Secondary	Occurrence of adverse events grade = 3 as assessed by CTCAEv5		100 days
Secondary	Severity and duration of grade = 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.		Day 0 to hospital discharge
Secondary	Time to neutrophil engraftment		First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/µL
Secondary	Time to platelet engraftment		First of seven consecutive days after ASCT of platelet count = 20,000/µL without transfusion support
Secondary	Time to lymphoid recovery		14, 28 and 100 days post-ASCT
Secondary	Progression-free survival		100 and 365 days post-ASCT
Secondary	Non-relapse mortality		100 and 365 days post-ASCT
Secondary	Overall survival		100 and 365 days post-ASCT