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

Acepodia Biotech

Status and phase: Enrolling; Phase 1

Conditions: Primary Mediastinal Large B Cell Lymphoma; Marginal Zone Lymphoma; Follicular Lymphoma; B-cell Lymphoma; DLBCL; Non Hodgkin Lymphoma

Treatments: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: ACE1831; Drug: Obinutuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05653271

ACE1831-001

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Treatment Group A (ACE1831)

Experimental group

Description:

ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.

Treatment:

Drug: ACE1831

Drug: Fludarabine

Drug: Cyclophosphamide

Treatment Group B (ACE1831 and obinutuzumab)

Experimental group

Description:

ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.

Treatment:

Drug: Obinutuzumab

Drug: ACE1831

Drug: Fludarabine

Drug: Cyclophosphamide