B-cell LymphomaPhase 1NCT05653271
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
A Phase 1 study testing Cyclophosphamide, Fludarabine and ACE1831 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, run by Acepodia Biotech, Inc. at 13 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL
- What is being tested?
- Cyclophosphamide, Fludarabine and ACE1831
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 21 Jan 2023to 31 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Taiwan7 sites
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Kaohsiung
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
Tamsui MacKay Memorial Hospital
New Taipei City
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Tainan
National Taiwan University Hospital
Taipei, Taipei
Linkou Chang-Gung Memorial Hospital
Taoyuan City
United States5 sites
Emory University
Atlanta, Georgia, 30322
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Norton Cancer Institute
Louisville, Kentucky, 40207
AdventHealth Orlando
Orlando, Florida, 32804
About this study
Official title: 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
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
- Being tested
- Cyclophosphamide, Fludarabine, ACE1831, Obinutuzumab
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Lymphodepleting agent
FludarabineDrug
Lymphodepleting agent
ACE1831Drug
Allogeneic gamma delta T (gdT) cell therapy
ObinutuzumabDrug
Anti-CD20 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A (ACE1831) | Experimental | ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831. Receives: 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. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE1831; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Measured: 2 years
Change from baseline in ECOG status
Measured: 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)
Measured: 1 year
Change from baseline clinical laboratory tests results
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Measured: 1 year
Change from baseline in urinalysis results
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Measured: 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)
Measured: 1 year
Change from baseline in electrocardiogram (ECG) results
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
Measured: 1 month
Maximum Tolerated Dose (MTD)
Measured: 1 month
Secondary outcomes (3)
Persistence of ACE1831 after administration
Half-life of ACE1831
Measured: 1 month
Measure of anti-ACE1831 antibodies after administration
Titration of anti-ACE1831 antibodies after administration
Measured: 1 month
Objective Response Rate (ORR)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start21 Jan 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acepodia Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653271
- Sponsor's protocol ID
- ACE1831-001
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05653271
- Acronym / sponsor ID
- ACE1831-001
- Conditions
- B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL, Primary Mediastinal Large B Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Acepodia Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A (ACE1831) | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: ACE1831ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831. |
| Treatment Group B (ACE1831 and obinutuzumab) | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Drug: ACE1831, Drug: ObinutuzumabACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideLymphodepleting agent | Drug | Treatment Group A (ACE1831), Treatment Group B (ACE1831 and obinutuzumab) |
| FludarabineLymphodepleting agent | Drug | Treatment Group A (ACE1831), Treatment Group B (ACE1831 and obinutuzumab) |
| ACE1831Allogeneic gamma delta T (gdT) cell therapy | Drug | Treatment Group A (ACE1831), Treatment Group B (ACE1831 and obinutuzumab) |
| ObinutuzumabAnti-CD20 monoclonal antibody | Drug | Treatment Group B (ACE1831 and obinutuzumab) |
Primary outcome
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Time frame: 2 years
Change from baseline in ECOG status
Time frame: 1 year
Change from baseline in physical examination results
Time frame: 1 year
Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)
Change from baseline clinical laboratory tests results
Time frame: 1 year
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Change from baseline in urinalysis results
Time frame: 1 year
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Change from baseline in vital signs results
Time frame: 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
Time frame: 1 month
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
Maximum Tolerated Dose (MTD)
Time frame: 1 month
3 secondary outcomes
Persistence of ACE1831 after administration
Time frame: 1 month
Measure of anti-ACE1831 antibodies after administration
Time frame: 1 month
Objective Response Rate (ORR)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Fludarabine and ACE1831 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, run by Acepodia Biotech, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan, United States, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs) (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.