Clinical trial NCT05653271: ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Lymphoma
Non Hodgkin Lymphoma
DLBCL
Primary Mediastinal Large B Cell Lymphoma
Marginal Zone Lymphoma
Follicular Lymphoma
Lead sponsor: Acepodia Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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
* 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, 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

Primary outcomes:
measure: Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
timeFrame: 2 years
measure: Change from baseline in ECOG status
timeFrame: 1 year
measure: Change from baseline in physical examination results
timeFrame: 1 year
measure: Change from baseline clinical laboratory tests results
timeFrame: 1 year
measure: Change from baseline in urinalysis results
timeFrame: 1 year
measure: Change from baseline in vital signs results
timeFrame: 1 year
measure: Change from baseline in electrocardiogram (ECG) results
timeFrame: 1 month
measure: Maximum Tolerated Dose (MTD)
timeFrame: 1 month
Secondary outcomes:
measure: Persistence of ACE1831 after administration
timeFrame: 1 month
measure: Measure of anti-ACE1831 antibodies after administration
timeFrame: 1 month
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Other outcomes:
measure: Pharmacodynamics of ACE1831
timeFrame: 2 years
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Simon Comprehensive Cancer Center
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: New Taipei City
country: Taiwan
facility: Tamsui MacKay Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Linkou Chang-Gung Memorial Hospital
Study officials:
References: