What side effects are associated with this type of intervention?

CAR-T cell therapies targeting CD19, such as CTX110, are commonly used for treating B-cell malignancies. Known side effects of these treatments include cytokine release syndrome (CRS), which can cause fever, hypotension, and respiratory distress, and neurotoxicity, which can manifest as confusion, seizures, or encephalopathy. Other side effects may include cytopenias (low blood cell counts), infections, and fatigue. These adverse effects can be serious and potentially life-threatening, requiring close monitoring and management.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies targeting CD19 for the treatment of B-cell cancers. Notable examples include tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). Tisagenlecleucel was the first CAR-T therapy approved in 2017 for treating pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and later for adult patients with relapsed or refractory large B-cell lymphoma. Axicabtagene ciloleucel was approved shortly after for adult patients with relapsed or refractory large B-cell lymphoma. These therapies have shown significant efficacy in achieving durable remissions in patients with otherwise limited treatment options.

What other types of research exist?

Promising novel alternatives to CTX110 for B-cell cancers in 2024 include: 1) Other CAR-T cell therapies like Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), which also target CD19. 2) Bispecific T-cell engagers (BiTEs) such as Blinatumomab, which brings T-cells in close proximity to cancer cells. 3) Monoclonal antibodies like Rituximab and Obinutuzumab, which target CD20. 4) Small molecule inhibitors like Ibrutinib and Acalabrutinib, which inhibit Bruton's tyrosine kinase (BTK). These therapies have shown efficacy in clinical trials and offer alternative mechanisms of action for treating B-cell malignancies.

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CAR T-cell Therapy

CTX110 for B-Cell Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by CRISPR Therapeutics AG

Eligibility Criteria Checklist

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

Must have

For NHL patients: Age ≥18 years.

For B cell ALL patients: age ≥18 years to ≤70 years.

Must not have

Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.

For NHL patients: prior allogeneic HSCT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ctx110 infusion up to 60 months post-infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CTX110, a treatment using modified immune cells from healthy donors, on patients with B-cell cancers that have not responded to other treatments. The immune cells are altered in a lab to better attack cancer cells using gene-editing technology.

Who is the study for?

This trial is for adults with B-cell malignancies like non-Hodgkin's lymphoma or acute lymphoblastic leukemia that didn't respond to at least two prior treatments. Participants must be in good physical condition, have well-functioning major organs, and not be pregnant or breastfeeding. They should agree to use contraception and join a follow-up study.

What is being tested?

The CARBON trial is testing the safety and effectiveness of CTX110, a new therapy for people with certain blood cancers that have come back or haven't responded to treatment. It's an early-phase study where everyone gets the same experimental treatment.

What are the potential side effects?

While specific side effects of CTX110 are not listed here, similar therapies can cause immune reactions, infections due to lowered immunity, fatigue, fever, and potential organ damage among other symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older with non-Hodgkin lymphoma.

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I am between 18 and 70 years old with B cell ALL.

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I am fully active or can carry out light work.

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I am at least 18 years old.

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My non-Hodgkin lymphoma or B cell ALL has not improved after at least 2 treatments.

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 ongoing serious infection requiring IV drugs.

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I have had a stem cell transplant from a donor for my lymphoma.

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I have not received gene or genetically modified cell therapies.

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I do not have active HIV, hepatitis B, or hepatitis C.

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My cancer has spread to my brain or spinal cord.

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I have an immune system disorder or autoimmune disease and am on steroids or other immune-weakening medicines.

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I have B cell ALL and had a bone marrow transplant within the last 6 months or have signs of graft-versus-host disease.

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I have a history of seizures, stroke, dementia, cerebellar disease, or autoimmune disease affecting my brain.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ctx110 infusion up to 60 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ctx110 infusion up to 60 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ctx110 infusion up to 60 months post-infusion 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

Objective Response Rate (for B cell ALL)

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: CTX110Experimental Treatment1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

0 / 14Eligibility 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

CAR-T cell therapy, such as CTX110, involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that specifically targets the CD19 protein found on the surface of B cells. Once these engineered T cells are infused back into the patient, they can recognize and kill CD19-expressing cancer cells. This targeted approach is significant for B-Cell Cancer patients because it offers a personalized treatment option that can lead to durable remissions, especially in cases where traditional therapies have failed. The specificity of CAR-T cells for CD19 helps to minimize damage to healthy cells, potentially reducing side effects compared to conventional chemotherapy.