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

NCT03925935 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AB-205-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Hodgkin Lymphoma; Non-hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5

  24 hours

Secondary Outcomes (8)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Up to 3 sequential dose escalation cohorts of AB-205

Biological: AB-205

Interventions

AB-205 BIOLOGICAL

Engineered human umbilical vein endothelial cells

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angiocrine Bioscience: lead
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (9)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UC San Diego Moores Cancer Center

San Diego, California, 92093, United States

Location

The University of California San Francisco

San Francisco, California, 94117, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Paul Finnegan, MD

  Angiocrine Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: AB-205 dose escalation based on safety.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: May 7, 2019
• Primary Completion: November 18, 2020
• Study Completion: November 8, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)