What side effects are associated with this type of intervention?

The most common treatments for Lymphocytic Leukemia, particularly CAR-T cell therapies targeting CD19 and CD22 antigens, are associated with several significant side effects. These include cytokine release syndrome (CRS), which can cause fever, hypotension, and respiratory distress, and neurotoxicity, which can lead to confusion, seizures, and encephalopathy. Other side effects include cytopenias (low blood cell counts), infections, and infusion reactions. Treatments like rituximab and bendamustine, often used in B-PLL, can also cause severe infusion reactions, particularly in the first cycle, and other side effects such as nausea, fatigue, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Lymphocytic Leukemia that target B-cell antigens similar to CD19/CD22-CAR T cells. Notably, acalabrutinib, a second-generation Bruton's tyrosine kinase inhibitor, has been approved for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Additionally, anti-CD20 monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab are commonly used in treatment regimens for chronic lymphocytic leukemia (CLL). These therapies aim to target and eliminate malignant B-cells, similar to the mechanism of CD19/CD22-CAR T cells.

What other types of research exist?

Promising novel alternatives to CD19/CD22-CAR T cells for lymphocytic leukemia patients include: 1) BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib), which target the B-cell receptor pathway. 2) Venetoclax, a BCL2 inhibitor, often combined with monoclonal antibodies like obinutuzumab. 3) Bispecific T cell engagers (BiTEs) such as teclistamab and AMG 701, which redirect T cells to target malignant B cells. 4) Antibody-drug conjugates like belantamab mafodotin, targeting BCMA. These alternatives offer different mechanisms of action and have shown efficacy in clinical trials.

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CAR T-cell Therapy

CAR T-Cell Therapy for Leukemia

Phase 1

Recruiting

Research Sponsored by Dr. Melody Smith, MD, MS

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 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment that uses special immune cells from a donor, modified to target and kill cancer cells, in adults with a specific type of blood cancer. These cells act like guided missiles, finding and destroying cancer cells by recognizing specific markers.

Who is the study for?

Adults aged 18-65 with B-cell Acute Lymphoblastic Leukemia who have a matched related donor for T cell and stem cell grafts. Participants should have high-risk ALL features or persistent disease after treatment, adequate organ function, and no history of certain infections or autoimmune CNS involvement. They must not be pregnant, breastfeeding, or unwilling to use birth control post-treatment.

What is being tested?

The trial tests the safety of CD19/CD22-CAR T cells from donors following myeloablative conditioning and Orca-T in adults with B-cell ALL. It aims to enhance leukemia defense without increasing acute GVHD (graft versus host disease) or graft failure.

What are the potential side effects?

Potential side effects may include immune reactions like acute GVHD where the body attacks the new cells, infection risks due to weakened immunity, organ inflammation from CAR T-cells, infusion-related reactions, and general discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Bone Transplantation

Number of patients who received donor CD19/CD22-CAR T cells

Secondary study objectives

Cumulative incidence of disease progression

Frequency of secondary graft failure

Infectious disease complication

+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: Dose escalationExperimental Treatment2 Interventions

Bayesian dose escalation design for the dosing of the donor CD19/CD22-CAR T cells

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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 Lymphocytic Leukemia include CAR T-cell therapies, BTK inhibitors, BCL2 inhibitors, and monoclonal antibodies. CAR T-cell therapies, such as CD19/CD22-CAR T cells, involve modifying a patient's T cells to target and eliminate malignant B-cells by recognizing specific antigens like CD19 and CD22. BTK inhibitors (e.g., ibrutinib) block Bruton's tyrosine kinase, disrupting B-cell receptor signaling and leading to cancer cell death. BCL2 inhibitors (e.g., venetoclax) promote apoptosis in cancer cells by inhibiting the BCL2 protein, which normally helps cells survive. Monoclonal antibodies (e.g., rituximab) target specific proteins on the surface of cancer cells, marking them for destruction by the immune system. These treatments are crucial as they offer targeted approaches to eliminate malignant cells, improve patient outcomes, and manage disease progression.

Cellular Therapy Advances in Chronic Lymphocytic Leukemia and Richter's Syndrome.