What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those targeting CD20-expressing B-cell malignancies like ACE1831, often include cell therapies and immunotherapies. These treatments can cause side effects such as cytokine release syndrome (CRS), neurotoxicity, and infusion-related reactions. Hematologic toxicities like neutropenia, anemia, and thrombocytopenia are also common. Patients may experience infections due to immunosuppression, fatigue, and gastrointestinal symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) targeting CD20-expressing B-cell malignancies. Rituximab, a monoclonal antibody targeting CD20, was one of the first and remains a cornerstone in the treatment of NHL. More recently, CAR-T cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) have been approved for relapsed or refractory B-cell NHL. These therapies involve modifying a patient's own T cells to target CD19, another B-cell marker. While not identical to the allogeneic gamma delta T (gdT) cell therapy being studied in the ACE1831 trial, these treatments share a similar goal of harnessing the immune system to target and destroy malignant B cells.

What other types of research exist?

Promising novel alternatives to ACE1831 for Non-Hodgkin's Lymphoma patients include: 1) Brentuximab vedotin, an antibody-drug conjugate targeting CD30, which has shown high tumor response rates in relapsed or refractory Hodgkin lymphoma and some NHL subtypes. 2) CAR T-cell therapies such as Lisocabtagene Maraleucel (liso-cel) and Axicabtagene Ciloleucel, which target CD19 and have demonstrated significant efficacy in large B-cell lymphoma. 3) Nonmyeloablative allogeneic hematopoietic cell transplantation (HCT), which has shown promising survival rates in patients with indolent NHL. These alternatives offer different mechanisms of action and have shown potential in clinical trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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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.