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RECRUITINGPhase 1INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 or subjects with ECOG scores of 2 with a serum albumin of \>3.5 - Adequate hematologic and renal, hepatic, and cardiac function - Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air Key Who Should NOT Join This Trial: - Prior treatment with a genetically modified cell therapy product targeting CD20 - Autologous stem cell transplant within 6 weeks of willing to sign a consent form 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 weakened immune system virus (HIV) infection (however, subjects on anti-retroviral therapy for at least 4 weeks and with HIV viral loads of \<400 copies/mL are eligible), 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 weakened immune system 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion 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 or subjects with ECOG scores of 2 with a serum albumin of \>3.5 * Adequate hematologic and renal, hepatic, and cardiac function * Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air Key Exclusion Criteria: * 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 (however, subjects on anti-retroviral therapy for at least 4 weeks and with HIV viral loads of \<400 copies/mL are eligible), 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

Treatments Being Tested

DRUG

Cyclophosphamide

Lymphodepleting agent

DRUG

Fludarabine

Lymphodepleting agent

DRUG

ACE1831

Allogeneic gamma delta T (gdT) cell therapy

DRUG

Obinutuzumab

Anti-CD20 monoclonal antibody

Locations (13)

AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Queen Mary Hospital
Hong Kong, Hong Kong
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
Tamsui MacKay Memorial Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Linkou Chang-Gung Memorial Hospital
Taoyuan, Taiwan