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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Orlando

AdventHealth Orlando, Orlando, Florida, United States, 32804

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Indianapolis

Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
  • * At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • * Adequate hematologic and renal, hepatic, and cardiac function
  • * Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air
  • * Prior treatment with a genetically modified cell therapy product targeting CD20
  • * Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation
  • * History of central nervous system (CNS) lymphoma or primary CNS lymphoma
  • * History or presence of clinically relevant CNS disorder (e.g. epilepsy)
  • * Clinically significant active infection
  • * Currently active, clinically significant cardiovascular disease
  • * Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
  • * History of other malignancies with the exception of certain treated malignancies with no evidence of disease
  • * Primary immunodeficiency disorder
  • * Pregnant or lactating female
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Acepodia Biotech, Inc.,

Study Record Dates

2027-09