What side effects are associated with this type of intervention?

Common treatments for leukemia that involve targeting specific antigens and activating T-cells, such as bispecific antibodies and CAR-T cell therapies, often have significant side effects. These can include cytokine release syndrome (CRS), which is characterized by fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing. Another serious side effect is immune effector cell-associated neurotoxicity syndrome (ICANS), which can cause confusion, seizures, and brain swelling. Additionally, patients may experience infections due to the immunosuppressive nature of these treatments. Other side effects can include neutropenia, anemia, and thrombocytopenia, leading to increased risk of infections, fatigue, and bleeding.

What prior FDA approvals exist?

Blinatumomab is an FDA-approved bispecific antibody for the treatment of leukemia, specifically targeting CD3 on T-cells and CD19 on B-cell leukemia cells. This mechanism is similar to the CD30 biAb-AATC trial, which targets CD30-expressing cells and activates T-cells via CD3. Blinatumomab facilitates immune-mediated recognition and killing of leukemia cells by keeping T-cells and tumor cells in close proximity.

What other types of research exist?

Promising alternatives to CD30 biAb-AATC for leukemia patients include: 1) Bispecific T-cell engagers (BiTEs) such as blinatumomab, which targets CD19 on B-cells and CD3 on T-cells. 2) Chimeric Antigen Receptor (CAR) T-cell therapies, such as lisocabtagene maraleucel (liso-cel) and axicabtagene ciloleucel, which are engineered to target CD19 on B-cells. 3) Antibody-drug conjugates (ADCs) like inotuzumab ozogamicin, which targets CD22 on B-cells. These therapies have shown significant efficacy in clinical trials and are promising options for leukemia treatment in 2024.

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CAR T-cell Therapy

Immunotherapy for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Nathan Schloemer, MD

Research Sponsored by Medical College of Wisconsin

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment where a patient's immune cells are enhanced to better fight cancer. It targets adults whose CD30+ cancer has come back or resisted other treatments. The enhanced cells are designed to specifically attack cancer cells, making the immune system more effective against the disease.

Who is the study for?

This trial is for people aged 12-39 with certain CD30+ cancers like lymphoma and leukemia, who have measurable disease and no effective standard treatments left. They must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and haven't had some other cancer in the last 5 years.

What is being tested?

The trial tests a new immunotherapy using patients' own T-cells armed with a special CD30 antibody against their cancer. It's the first time this treatment is being tried on humans to see if it's safe and works.

What are the potential side effects?

Potential side effects aren't specified but may include typical immune-related reactions such as fever, fatigue, allergic responses to the therapy components, or worsening of underlying conditions due to immune system activation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Define Toxicities - CTCAE v5.0

Maximum Tolerated Dose

Secondary study objectives

Define anti-tumor activity - Objective Response Rate

Antineoplastic Agents

In vitro activity - quantitative cytotoxicity

+2 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: CD30biAb-AATCExperimental Treatment1 Intervention

Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF in 4-week cycles for a maximum of two total cycles.

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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

Common treatments for leukemia, particularly those involving immunotherapy, often utilize mechanisms that target specific antigens on leukemia cells and activate the patient's immune system to attack these cells. For example, bispecific antibodies like the CD30 biAb-AATC target CD30-expressing leukemia cells and simultaneously activate T-cells via CD3, bringing them into close proximity to facilitate targeted cell killing. CAR-T cell therapy involves genetically modifying a patient's T-cells to express receptors specific to antigens on leukemia cells, enhancing their ability to recognize and destroy these cancer cells. BiTEs (bispecific T-cell engagers) also work by binding to both T-cells and cancer cells, promoting immune-mediated cell death. These treatments are significant for leukemia patients as they offer targeted approaches that can potentially lead to more effective and less toxic therapies compared to traditional chemotherapy.

T lymphocytes can be effectively recruited for ex vivo and in vivo lysis of AML blasts by a novel CD33/CD3-bispecific BiTE antibody construct.