ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
- Conditions
- DLBCLMarginal Zone LymphomaFollicular LymphomaB-cell LymphomaPrimary Mediastinal Large B Cell LymphomaNon Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT05653271
- Lead Sponsor
- Acepodia Biotech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment Group B (ACE1831 and obinutuzumab) Fludarabine ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab. Treatment Group A (ACE1831) ACE1831 ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831. Treatment Group A (ACE1831) Fludarabine ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831. Treatment Group A (ACE1831) Cyclophosphamide ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831. Treatment Group B (ACE1831 and obinutuzumab) ACE1831 ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab. Treatment Group B (ACE1831 and obinutuzumab) Cyclophosphamide ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab. Treatment Group B (ACE1831 and obinutuzumab) Obinutuzumab ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.
- Primary Outcome Measures
Name Time Method Change from baseline in ECOG status 1 year Change from baseline clinical laboratory tests results 1 year Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Change from baseline in vital signs results 1 year Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive)
Maximum Tolerated Dose (MTD) 1 month Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs) 2 years Change from baseline in physical examination results 1 year Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)
Change from baseline in urinalysis results 1 year Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Change from baseline in electrocardiogram (ECG) results 1 month Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 2 years Objective response of each patient's underlying lymphoma, duration of response, and progression-free survival all based on the revised IWG Response Criteria for Malignant Lymphoma
Measure of anti-ACE1831 antibodies after administration 1 month Titration of anti-ACE1831 antibodies after administration
Persistence of ACE1831 after administration 1 month Half-life of ACE1831
Trial Locations
- Locations (7)
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
Linkou Chang-Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
Tamsui MacKay Memorial Hospital
🇨🇳New Taipei City, Taiwan