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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03925935

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted March 6, 2020

Study Description

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.

  • Condition or Disease:Hodgkin Lymphoma
    Non-hodgkin Lymphoma
  • Intervention/Treatment: Biological: AB-205
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 24 participants
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: AB-205 dose escalation based on safety.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: March 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Experimental
Up to 3 sequential dose escalation cohorts of AB-205
Biological: AB-205
Engineered human umbilical vein endothelial cells
Outcome Measures
  • Primary Outcome Measures: 1. Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 [ Time Frame: 24 hours ]
  • Secondary Outcome Measures: 1. Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 [ Time Frame: 100 days ]
  • 2. Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea. [ Time Frame: Day 0 to hospital discharge ]
  • 3. Time to neutrophil engraftment [ Time Frame: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL ]
  • 4. Time to platelet engraftment [ Time Frame: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support ]
  • 5. Time to lymphoid recovery [ Time Frame: 14, 28 and 100 days post-ASCT ]
  • 6. Progression-free survival [ Time Frame: 100 and 365 days post-ASCT ]
  • 7. Non-relapse mortality [ Time Frame: 100 and 365 days post-ASCT ]
  • 8. Overall survival [ Time Frame: 100 and 365 days post-ASCT ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Gayle Bresnahan 858-220-1046 gbresnahan@angiocrinebio.com

Contact: John Jaskowiak 408-646-2265 jjaskowiak@angiocrinebio.com

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte

United States, California
UC Davis Comprehensive Cancer Center
Sacramento

United States, California
UC San Diego Moores Cancer Center
San Diego

United States, California
The University of California San Francisco
San Francisco

United States, Michigan
University of Michigan
Ann Arbor

United States, New York
Memorial Sloan Kettering Cancer Center
New York

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville

United States, Texas
MD Anderson
Houston

Sponsors and Collaborators

Angiocrine Bioscience

California Institute for Regenerative Medicine (CIRM)

Investigators

Study Director: Edward Kavalerchik, MD Angiocrine Bioscience

More Information
  • Responsible Party: Angiocrine Bioscience
  • ClinicalTrials.gov Identifier: NCT03925935 History of Changes
  • Other Study ID Numbers: AB-205-001
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: March 6, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lymphoma