What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include chemotherapy, targeted therapies, and CAR-T cell therapies. Chemotherapy can cause side effects such as nausea, fatigue, cytopenias, and increased risk of infections. Targeted therapies, like ibrutinib, may lead to diarrhea, bleeding, and cardiac issues. CAR-T cell therapies, such as those targeting CD19, can result in serious side effects including cytokine release syndrome (CRS), neurotoxicity, cytopenias, and infections. These side effects are significant and require careful management during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Lymphocytic Leukemia (CLL), including CAR-T cell therapies targeting malignant B-cells. One notable CAR-T therapy is brexucabtagene autoleucel (KTE-X19), which has shown efficacy in relapsed or refractory mantle cell lymphoma, a related B-cell malignancy. Additionally, other targeted therapies for CLL include ibrutinib, venetoclax, and obinutuzumab, which have been approved for their effectiveness in treating CLL by targeting specific pathways and proteins involved in the disease.

What other types of research exist?

Promising novel alternatives to CTX112™ for CLL patients include: 1) Other CAR-T cell therapies such as lisocabtagene maraleucel and axicabtagene ciloleucel, which target CD19 on malignant B-cells. 2) BTK inhibitors like ibrutinib, acalabrutinib, and zanubrutinib, which have shown high response rates and prolonged progression-free survival. 3) Venetoclax, a BCL2 inhibitor, often used in combination with obinutuzumab for deep remissions. 4) Bispecific T cell engagers (BiTEs) like teclistamab and AMG 701, which target both T cells and malignant B-cells. These therapies offer promising efficacy and are under active investigation or have shown positive results in clinical trials.

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CAR T-cell Therapy

CTX112 for B-Cell Cancers

Phase 1 & 2

Recruiting

Research Sponsored by CRISPR Therapeutics AG

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 date of first objective response of complete response (cr)/partial response (pr) until date of disease progression or death due to any cause, assessed up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CTX112, a modified immune cell therapy, in patients with B-cell cancers that have returned or resisted other treatments. The therapy uses CRISPR-Cas9 to enhance donor immune cells to better target and attack cancer cells. CRISPR-Cas9 technology has been increasingly used in cancer immunotherapy, including the preparation of CAR T cells for antitumor therapy.

Who is the study for?

Adults over 18 with certain B-cell cancers that have come back or didn't respond to treatment can join. They must be fairly active and healthy, with good heart, kidney, liver, and lung function. Participants need to use birth control during the trial and for a year after getting the study drug.

What is being tested?

The trial is testing CTX112's safety and effectiveness in patients with various types of B-cell malignancies that are resistant or have relapsed. It's an early-phase study where everyone gets the same experimental therapy.

What are the potential side effects?

Specific side effects of CTX112 aren't listed here but may include typical reactions related to immune therapies such as fatigue, fever, chills, weakness, infection risk increase, nausea or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first objective response of complete response (cr)/partial response (pr) until date of disease progression or death due to any cause, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first objective response of complete response (cr)/partial response (pr) until date of disease progression or death due to any cause, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first objective response of complete response (cr)/partial response (pr) until date of disease progression or death due to any cause, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Duration of Response

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: CTX112Experimental Treatment1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

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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 Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors, BCL2 inhibitors, monoclonal antibodies, and CAR-T cell therapies. BTK inhibitors, such as ibrutinib, block the BTK enzyme, which is crucial for the survival and proliferation of malignant B-cells. BCL2 inhibitors, like venetoclax, induce apoptosis in cancer cells by inhibiting the BCL2 protein that prevents cell death. Monoclonal antibodies, such as rituximab, target specific antigens on the surface of CLL cells, marking them for destruction by the immune system. CAR-T cell therapies, including those similar to CTX112™, involve modifying a patient's T-cells to express a receptor that specifically targets and kills malignant B-cells. These treatments are vital for CLL patients as they offer targeted approaches to eliminate cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.