B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL, Primary Mediastinal Large B Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, Burkitt Lymphoma, High-grade B-cell Lymphoma
Conditions
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.
Interventions
DRUGCyclophosphamide
Lymphodepleting agent
DRUGFludarabine
Lymphodepleting agent
DRUGACE1831
Allogeneic gamma delta T (gdT) cell therapy
DRUGObinutuzumab
Anti-CD20 monoclonal antibody
Sponsors
Acepodia Biotech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 1 month | — |
| 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 urinalysis results | 1 year | Number of subjects with change from baseline clinically significant urinalysis 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) |
| Change from baseline in electrocardiogram (ECG) results | 1 month | Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive) |
| 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 ECOG status | 1 year | — |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics of ACE1831 | 2 years | Serum levels of interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10, as well as other potential biomarkers |
Countries
Hong Kong, Taiwan, United States
Contacts
Primary ContactStephanie Chien
Outcome results
None listed