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CAR T-cell Therapy

ACE1831 Cell Therapy for B-Cell Lymphoma

Phase 1
Recruiting
Research Sponsored by Acepodia Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing ACE1831, a cell therapy made from healthy donors' immune cells, in patients with CD20-expressing Non-Hodgkin lymphoma. The therapy aims to use special immune cells to target and kill cancer cells with the CD20 marker. Rituximab, a monoclonal antibody targeting CD20, has been widely used in treating B-cell malignancies such as non-Hodgkin's lymphoma.

Who is the study for?
This trial is for adults with certain types of B-cell Non-Hodgkin's Lymphoma that have tried at least two other treatments without success. Participants should be relatively healthy, able to perform daily activities with ease (ECOG 0-1), and not have a history of central nervous system lymphoma or other significant health issues like active infections or severe heart disease.
What is being tested?
The study tests ACE1831, an experimental cell therapy made from donor T cells targeting CD20 in B-cell malignancies. It's given alongside standard drugs Cyclophosphamide, Fludarabine, and Obinutuzumab to see how safe it is and how well it works against the cancer.
What are the potential side effects?
Potential side effects may include reactions related to immune cell infusion, effects on blood counts due to chemotherapy agents (Cyclophosphamide and Fludarabine), as well as possible infusion-related reactions from the antibody treatment (Obinutuzumab).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline clinical laboratory tests results
Change from baseline in electrocardiogram (ECG) results
Change from baseline in physical examination results
+2 more
Secondary study objectives
Measure of anti-ACE1831 antibodies after administration
Objective Response Rate (ORR)
Persistence of ACE1831 after administration
Other study objectives
Pharmacodynamics of ACE1831

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Group B (ACE1831 and obinutuzumab)Experimental Treatment4 Interventions
ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.
Group II: Treatment Group A (ACE1831)Experimental Treatment3 Interventions
ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3470
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) targeting CD20-expressing B-cell malignancies include monoclonal antibodies, CAR-T cell therapy, and allogeneic T cell therapies. Monoclonal antibodies, such as rituximab, bind to the CD20 antigen on B-cells, leading to cell death through mechanisms like antibody-dependent cellular cytotoxicity and complement activation. CAR-T cell therapy involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that specifically targets CD20, resulting in direct killing of the malignant B-cells. Allogeneic gamma delta T (gdT) cell therapy, like ACE1831, uses donor-derived T cells that can recognize and kill cancer cells without the need for patient-specific modification. These therapies are crucial for NHL patients as they offer targeted approaches that can lead to more effective and potentially less toxic treatments compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Acepodia Biotech, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

ACE1831 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05653271 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Treatment Group A (ACE1831), Treatment Group B (ACE1831 and obinutuzumab)
Non-Hodgkin's Lymphoma Clinical Trial 2023: ACE1831 Highlights & Side Effects. Trial Name: NCT05653271 — Phase 1
ACE1831 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653271 — Phase 1
~14 spots leftby Sep 2025