RECRUITING

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies. The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.

Official Title

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic CD20-conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies

Quick Facts

Study Start:2023-01-21
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05653271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
  2. * At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. * Adequate hematologic and renal, hepatic, and cardiac function
  5. * Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air
  1. * Prior treatment with a genetically modified cell therapy product targeting CD20
  2. * Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation
  3. * History of central nervous system (CNS) lymphoma or primary CNS lymphoma
  4. * History or presence of clinically relevant CNS disorder (e.g. epilepsy)
  5. * Clinically significant active infection
  6. * Currently active, clinically significant cardiovascular disease
  7. * Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
  8. * History of other malignancies with the exception of certain treated malignancies with no evidence of disease
  9. * Primary immunodeficiency disorder
  10. * Pregnant or lactating female
  11. * Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent

Contacts and Locations

Study Contact

Stephanie Chien
CONTACT
+1 415-366-7822
clinical@acepodiabio.com

Study Locations (Sites)

AdventHealth Orlando
Orlando, Florida, 32804
United States
Emory University
Atlanta, Georgia, 30322
United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Acepodia Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-21
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-01-21
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • B-cell Lymphoma
  • Non Hodgkin Lymphoma
  • DLBCL
  • Primary Mediastinal Large B Cell Lymphoma
  • Marginal Zone Lymphoma
  • Follicular Lymphoma