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TerminatedNCT05181540E-CELERATEUpdated Feb 4, 2025

A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation

A Phase 3 interventional study of AB-205 and Placebo in Hodgkin Lymphoma and Non Hodgkin Lymphoma, sponsored by Angiocrine Bioscience. Terminated at 28 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Angiocrine Bioscience · Phase 3, Interventional, and Supportive care

Why this study was terminated
Interim analysis showed lack of efficacy

From the registry’s dates

  • Primary completion was Dec 2023, 2 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs.

The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.

02

Conditions studied

  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma

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Keywords

  • Lymphoma
  • Cellular Therapy
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 130 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Angiocrine Bioscience is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 40 years old
  2. Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
  3. Candidates for HDT-AHCT with one of the following conditioning regimens:

    1. BEAM (carmustine, etoposide, cytarabine, melphalan)
    2. BeEAM (bendamustine, etoposide, cytarabine, melphalan)
  4. Achieved CR or PR prior to planned HDT
  5. ECOG ≤ 2
  6. Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula
  7. Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
  8. AST, ALT, and alkaline phosphatase \< 3 × ULN
  9. Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault)
  10. LVEF ≥ 45% by MUGA or resting echocardiogram
  11. Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
  12. Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
  13. Sexually active females of childbearing potential must have a negative urine pregnancy test and agree to use two accepted methods of contraception during the study and for 3 months after their last dose of study drug.
  14. Male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as in criterion 12 above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
  15. Ability to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. History of prior HCT
  2. Primary CNS lymphoma
  3. Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
  4. Active malignancy other than the one for which the subject is undergoing HDT AHCT. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible
  5. 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
  6. Subjects with a known history of HIV
  7. Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO
  8. Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    AB-205 plus standard-of-care preventive and supportive therapies.

    Biological: AB-205

  • Placebo comparator
    Placebo plus standard-of-care preventive and supportive therapies.

    Other: Placebo

Interventions

  • BiologicalAB-205

    Allogeneic genetically engineered human umbilical vein endothelial cells

    Also known as: E-CEL cells

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).

    Time frame: 21 Days

Secondary outcomes

  1. Duration of oral/GI SRRT

    Time frame: 21 Days

  2. Symptom burden per MD Anderson Symptom Inventory (MDASI)

    Time frame: 21 Days

  3. Duration of febrile neutropenia

    Time frame: 21 Days

  4. Time to neutrophil engraftment

    Time frame: 21 Days

07

Study locations

28 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
  • UC Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • UC San Diego Moores Cancer Center
    San Diego, California 92093, United States
  • Sarah Cannon Research Institute, Colorado
    Denver, Colorado 80218, United States
  • Medstar Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • University of Miami - Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9416, United States
  • Emory University - Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • University of Illinois Cancer Center
    Chicago, Illinois 60612, United States
  • Indiana University Simon Comprehensive Cancer Center
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
  • University Of Maryland School Of Medicine
    Baltimore, Maryland 21201, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • University of Minnesota Medical Center, Fairview
    Minneapolis, Minnesota 55455, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Weill Cornell Medical College/New York Presbyterian Hospital
    New York, New York 10065, United States
  • The Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Sarah Cannon Research Institute, Nashville
    Nashville, Tennessee 37203, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37203, United States
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05181540
Lead sponsor
Angiocrine Bioscience
Collaborators
California Institute for Regenerative Medicine (CIRM)
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Feb 21, 2022
Primary completion
Dec 29, 2023
Completion
Jan 31, 2025
Last update
Feb 4, 2025

Study contacts

Paul Finnegan, MD
study director · Angiocrine Bioscience, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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