What is the mechanism of action of this treatment?

CAR-T cell therapy, such as the UCART20x22 trial targeting CD20 and CD22, involves engineering a patient's T cells to express chimeric antigen receptors that specifically target these antigens on lymphoma cells. This enables the T cells to identify and destroy the cancer cells effectively. This mechanism is crucial for Non-Hodgkin's Lymphoma patients, particularly those with relapsed or refractory disease, as it provides a highly targeted treatment option that can potentially lead to long-term remission when other therapies have not been successful.

What side effects are associated with this type of intervention?

CAR-T cell therapies for Non-Hodgkin's Lymphoma, including those targeting CD20 and CD22 like UCART20x22, are associated with several notable side effects. Common adverse effects include cytokine release syndrome (CRS), which can cause fever, hypotension, and respiratory distress, and neurotoxicity, which may manifest as confusion, seizures, or encephalopathy. Other potential side effects include infections due to immunosuppression, cytopenias (low blood cell counts), and infusion-related reactions. These therapies require careful monitoring and management to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of Non-Hodgkin's Lymphoma. Notably, axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-directed CAR-T therapies approved for relapsed or refractory cases. These therapies have shown high response rates and durable remissions in clinical trials. While the context does not mention specific FDA approvals for CAR-T therapies targeting CD20 and CD22, the ongoing study of UCART20x22 aims to explore this novel approach in B-Cell Non-Hodgkin Lymphoma.

What other types of research exist?

Promising novel alternatives to UCART20x22 for Non-Hodgkin's Lymphoma patients include: 1) Anti-CD19 CAR T-cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), which have shown significant efficacy in relapsed/refractory B-cell NHL. 2) Tafasitamab (MOR208) combined with lenalidomide, which targets CD19 and has demonstrated progression-free survival benefits in clinical trials. 3) Bispecific T-cell engagers (BiTEs) like blinatumomab, which simultaneously target CD19 on B-cells and CD3 on T-cells to direct T-cell cytotoxicity towards malignant B-cells. These alternatives offer different mechanisms of action and have shown promising results in clinical settings.

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CAR T-cell Therapy

Gene Therapy for Non-Hodgkin's Lymphoma (NatHaLi-01 Trial)

Phase 1 & 2

Recruiting

Led By Jeremy Abramson, MD

Research Sponsored by Cellectis S.A.

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 from study entry through month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing UCART20x22, a treatment using modified immune cells, in patients with B-Cell Non-Hodgkin Lymphoma that has returned or resisted other treatments. The goal is to see how safe it is and how well it works.

Who is the study for?

This trial is for adults with B-Cell Non-Hodgkin Lymphoma that has come back or hasn't responded to treatment. They must have tried at least two prior treatments, including a specific type of cell therapy if available. People can't join if they've had certain other recent treatments, infections, hypersensitivity reactions, uncontrolled diseases, or another cancer within the last 2 years.

What is being tested?

The study tests UCART20x22 (a new therapy) in people with relapsed/refractory B-NHL to find out how safe it is and what dose works best. It's an early-stage trial where everyone gets the experimental treatment intravenously and doctors closely monitor their response.

What are the potential side effects?

Potential side effects aren't listed but may include typical reactions to immunotherapies such as fever, fatigue, infusion-related reactions and increased risk of infection due to immune system modification.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study entry through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study entry through month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry through month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]

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 finding partExperimental Treatment2 Interventions

UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified. Dose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part

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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

CAR-T cell therapy, such as the UCART20x22 trial targeting CD20 and CD22, involves engineering a patient's T cells to express chimeric antigen receptors that specifically target these antigens on lymphoma cells. This enables the T cells to identify and destroy the cancer cells effectively. This mechanism is crucial for Non-Hodgkin's Lymphoma patients, particularly those with relapsed or refractory disease, as it provides a highly targeted treatment option that can potentially lead to long-term remission when other therapies have not been successful.