What side effects are associated with this type of intervention?

Common treatments for multiple myeloma, particularly CAR-T cell therapies like CTX120, often involve significant side effects. These can include cytokine release syndrome (CRS), which manifests as fever, fatigue, and hypotension, and neurotoxicity, which can lead to confusion, seizures, or encephalopathy. Other side effects may include cytopenias (low blood cell counts), infections, and organ toxicities such as cardiac or renal complications. These adverse events can be severe and require careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of Multiple Myeloma, including idecabtagene vicleucel and ciltacabtagene autoleucel. These therapies involve genetically modified T cells that target cancer cells, similar to the investigational CTX120. Other related treatments include bispecific T cell engagers and BCMA-targeting antibody-drug conjugates, which also aim to enhance the immune system's ability to fight Multiple Myeloma.

What other types of research exist?

Promising alternatives to CTX120 for Multiple Myeloma patients include: 1) Idecabtagene vicleucel (ide-cel, bb2121) - another CAR-T cell therapy targeting BCMA, showing significant efficacy in clinical trials. 2) Ciltacabtagene autoleucel (cilta-cel, JNJ-4528) - a BCMA-directed CAR-T cell therapy with promising results in heavily pretreated patients. 3) Bispecific antibodies like Teclistamab - targeting BCMA and CD3, offering a novel mechanism of action. 4) Selinexor - a selective inhibitor of nuclear export, used in combination with other agents like bortezomib and dexamethasone. 5) Venetoclax - particularly effective in patients with t(11;14) translocation, often used in combination with other therapies.

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CAR T-cell Therapy

CTX120 for Multiple Myeloma

Phase 1

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

Age ≥18 years

Eastern Cooperative Oncology Group performance status 0 or 1

Must not have

Prior allogeneic stem cell transplant (SCT)

Active HIV, hepatitis B virus or hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ctx120 infusion up to 60 months post-infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called CTX120. It is aimed at patients with a type of blood cancer that has come back or not responded to other treatments. The goal is to see if CTX120 is safe and effective in these patients.

Who is the study for?

This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment after at least two prior therapies. They must be fairly active and healthy, with good organ function, and willing to use birth control for a year post-treatment. People can't join if they've had certain other treatments like gene therapy, have heart issues or infections like HIV, are pregnant/breastfeeding, or have serious mental health conditions.

What is being tested?

The study is testing CTX120's safety and effectiveness in treating relapsed or refractory multiple myeloma. It's an early-phase (Phase 1), single-arm trial where all participants receive the same experimental therapy without a comparison group.

What are the potential side effects?

While specific side effects of CTX120 aren't listed here, similar treatments often cause immune reactions, fatigue, fever, nausea; there may also be risks related to cell infusions such as shortness of breath or allergic reactions.

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.

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I am fully active or can carry out light work.

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My multiple myeloma has returned or didn't respond to treatment, and I've had at least 2 prior treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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My multiple myeloma has returned or didn't respond after 2 treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant from a donor.

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

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I am not pregnant or breastfeeding.

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I have an immune system disorder or autoimmune disease treated with steroids or other immune-suppressing drugs.

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It's been less than 60 days since my stem cell transplant and I have serious ongoing complications.

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I have not had gene or genetically modified cell therapy, like CAR T.

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I have a significant brain-related health condition.

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My multiple myeloma has spread to my brain or spinal cord.

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I haven't taken any cancer drugs or been in a trial for new treatments in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ctx120 infusion up to 60 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ctx120 infusion up to 60 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ctx120 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.

Primary study objectives

Part A (dose escalation): Incidence of adverse events

Part B (cohort expansion): Objective response rate

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: CTX120Experimental Treatment1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

0 / 15Eligibility 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 the CTX120 trial, involves genetically modifying a patient's T cells to express chimeric antigen receptors (CARs) that specifically target and destroy cancer cells expressing B-cell maturation antigen (BCMA). This approach harnesses the body's immune system to fight Multiple Myeloma, offering a personalized and potent treatment option. Other common treatments include proteasome inhibitors (e.g., bortezomib), which disrupt protein degradation in cancer cells, and immunomodulatory drugs (e.g., lenalidomide), which enhance the immune response against myeloma cells. These treatments are crucial as they target different aspects of cancer cell survival and proliferation, providing multiple avenues to control and potentially eradicate the disease.

Chimeric antigen receptor T cell targeting B cell maturation antigen immunotherapy is promising for multiple myeloma.