What is the mechanism of action of this treatment?

Monoclonal antibodies such as rituximab (targeting CD20) and agents targeting CD19 are pivotal in treating Non-Hodgkin's Lymphoma (NHL). These treatments work by binding to specific antigens on B-cells, marking them for destruction by the immune system. This targeted approach allows for the selective elimination of malignant B-cells, resulting in fewer side effects compared to traditional chemotherapy. For NHL patients, this means more effective treatment options with potentially better outcomes and improved quality of life.

What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma targeting CD20 and/or CD19 on B-cells, such as rituximab and antibody-drug conjugates (ADCs), have several known side effects. Rituximab can cause severe infusion reactions, including fever, chills, and respiratory symptoms, particularly during the first cycle. ADCs, like sacituzumab govitecan, may lead to variable degrees of hair loss (22 to 53 percent) and other side effects depending on the specific toxin used. Combination therapies involving these agents, such as rituximab with bendamustine, often result in hematologic toxicities like neutropenia and thrombocytopenia, as well as non-hematologic toxicities such as infections and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma (NHL) that target CD20 and/or CD19 on B-cells. Anti-CD20 monoclonal antibodies, including rituximab, ofatumumab, and obinutuzumab, are widely used and work by targeting the CD20 antigen on B-cells, leading to their destruction. Additionally, CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which target CD19, have been approved for certain types of NHL. These therapies involve modifying a patient's T-cells to specifically target and kill CD19-positive B-cells.

What other types of research exist?

Promising novel alternatives to 1A46 for NHL patients include: 1) CAR T-cell therapies targeting CD19, such as axicabtagene ciloleucel and tisagenlecleucel, which have shown high efficacy in relapsed or refractory B-cell lymphomas. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target both CD19 on B-cells and CD3 on T-cells to direct the immune system to attack cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which targets CD79b and delivers cytotoxic agents directly to B-cells. 4) Novel monoclonal antibodies like tafasitamab, which targets CD19 and is used in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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Monoclonal Antibodies

1A46 Injection for Non-Hodgkin's Lymphoma and Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Chimagen Biosciences, Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aggressive NHL Patients with specified histologies and treatment history

Indolent NHL Patients with specified histologies and treatment history

Must not have

Active hepatitis B or C infection

Recent cardiovascular events or heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to end of study or discontinuation due to disease progression, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment called 1A46 for adults with advanced blood cancers that haven't responded to other treatments. The treatment works by targeting proteins on cancer cells, helping the immune system destroy them.

Who is the study for?

Adults with advanced B-cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia that have tried at least two other treatments and can't undergo or haven't benefited from stem cell transplant. They must not be using high-dose steroids, have active hepatitis, recent heart issues, major surgery, uncontrolled diseases, severe allergies to monoclonal antibodies, COVID-19 infection, another cancer within the last 5 years (with some exceptions), certain heart conditions or neurological issues.

What is being tested?

The trial is testing a new injection called 1A46 for its safety and effectiveness in treating adults with specific types of blood cancers that express CD20 and/or CD19 proteins. The study will include patients who have already undergone multiple previous therapies without success.

What are the potential side effects?

While the exact side effects are not listed here as it's a first-in-human trial of 1A46, common side effects for similar treatments may include allergic reactions to the drug components, potential immune system activation leading to inflammation in various organs (immune-related adverse events), fatigue and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of aggressive non-Hodgkin lymphoma and a certain treatment history.

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I have a slow-growing type of non-Hodgkin lymphoma and a specific treatment history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active hepatitis B or C infection.

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I have had recent heart problems or heart failure.

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I have brain metastasis or a significant neurological condition.

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I am currently pregnant, breastfeeding, or lactating.

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I have fluid buildup needing treatment in my chest, heart, or abdomen.

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I am HIV positive.

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I currently have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to end of study or discontinuation due to disease progression, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to end of study or discontinuation due to disease progression, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of study or discontinuation due to disease progression, up to 5 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

Escalation: Dose liming toxicity (DLT)

Escalation: Incidence of Adverse Events

Secondary study objectives

Escalation: Anti-drug antibody (ADA)

Escalation: Area Under the Concentration-Time Curve (AUC) from Time 0 to t

Escalation: Area under the serum concentration-time curve from time 0 to infinity (AUCinf)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Open label, single arm trial where 1A46 will be administered

0 / 9Eligibility criteria met

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

Monoclonal antibodies such as rituximab (targeting CD20) and agents targeting CD19 are pivotal in treating Non-Hodgkin's Lymphoma (NHL). These treatments work by binding to specific antigens on B-cells, marking them for destruction by the immune system. This targeted approach allows for the selective elimination of malignant B-cells, resulting in fewer side effects compared to traditional chemotherapy. For NHL patients, this means more effective treatment options with potentially better outcomes and improved quality of life.