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

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

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.

Study Overview

• Status: Completed
• Conditions: Hodgkin Lymphoma; Non-hodgkin Lymphoma
• Intervention / Treatment: Biological: AB-205

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Comprehensive Cancer Center
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
    • San Diego, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • San Francisco, California, United States, 94117
      • The University of California San Francisco
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Up to 3 sequential dose escalation cohorts of AB-205	Biological: AB-205; Engineered human umbilical vein endothelial cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Angiocrine Bioscience
• Collaborators: California Institute for Regenerative Medicine (CIRM)

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: AB-205-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No