ACE1831 treatment for adults with relapsed B-cell cancers
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic Anti-CD20 Antibody-Conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies
This study is testing a new treatment called ACE1831 for adults with certain types of B-cell cancers that haven't improved with other therapies to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acepodia Biotech, Inc. Industry-sponsored |
| Locations | 13 sites (Orlando, Florida and 12 other locations) |
| Trial ID | NCT05653271 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial investigates ACE1831, an allogeneic gamma delta T cell therapy, for adults with CD20-expressing B-cell malignancies that have not responded to previous treatments. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ACE1831 in patients with conditions such as Non-Hodgkin lymphoma. Participants will receive ACE1831 along with other treatments like cyclophosphamide and obinutuzumab. The trial is open-label, meaning both the researchers and participants know the treatment being administered.
Who should consider this trial
Good fit: Ideal candidates are adults with CD20-positive B-cell non-Hodgkin lymphoma who have experienced disease progression after at least two prior systemic therapies.
Not a fit: Patients who have previously received genetically modified cell therapies targeting CD20 or those with active CNS disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Other studies involving gamma delta T cell therapies have shown promise, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / 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 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
Where this trial is running
Orlando, Florida and 12 other locations
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Terminated)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- Kaohsiung Chang-Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City, Taiwan (Recruiting)
- Tamsui MacKay Memorial Hospital — New Taipei City, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Linkou Chang-Gung Memorial Hospital — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Stephanie Chien
- Email: clinical@acepodiabio.com
- Phone: +1 415-366-7822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.