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

NCT05653271 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ACE1831-001
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 13

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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

  Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)

  1 year

• Change from baseline clinical laboratory tests results

  Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)

  1 year

• Change from baseline in urinalysis results

  Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)

  1 year

• Change from baseline in vital signs results

  Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive)

  1 year

• Change from baseline in electrocardiogram (ECG) results

  Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)

  1 month

• Maximum Tolerated Dose (MTD)

  1 month

Secondary Outcomes (3)

• Persistence of ACE1831 after administration

  1 month

• Measure of anti-ACE1831 antibodies after administration

  1 month

• Objective Response Rate (ORR)

  2 years

Other Outcomes (1)

• Pharmacodynamics of ACE1831

  2 years

Study Arms (2)

Treatment Group A (ACE1831)

EXPERIMENTAL

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

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE1831

Treatment Group B (ACE1831 and obinutuzumab)

EXPERIMENTAL

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

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

Interventions

Cyclophosphamide DRUG

Lymphodepleting agent

Treatment Group A (ACE1831); Treatment Group B (ACE1831 and obinutuzumab)

Fludarabine DRUG

Lymphodepleting agent

Treatment Group A (ACE1831); Treatment Group B (ACE1831 and obinutuzumab)

ACE1831 DRUG

Allogeneic gamma delta T (gdT) cell therapy

Treatment Group A (ACE1831); Treatment Group B (ACE1831 and obinutuzumab)

Obinutuzumab DRUG

Anti-CD20 monoclonal antibody

Treatment Group B (ACE1831 and obinutuzumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acepodia Biotech, Inc.: lead

Study Sites (13)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Location

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Location

Tamsui MacKay Memorial Hospital

New Taipei City, Taiwan

Location

Linkou Chang-Gung Memorial Hospital

Taoyuan City, Taiwan

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular; Burkitt Lymphoma

Interventions

Cyclophosphamide; fludarabine; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 16, 2022
• Study Start: January 21, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); US (5); TW (7)