What side effects are associated with this type of intervention?

Common treatments for T-Cell Lymphoma, particularly CD7-directed CAR T-cell therapies like WU-CART-007, are associated with several side effects. These include cytokine release syndrome (CRS), which can lead to multiorgan dysfunction and acute kidney injury, and serious infections. Other potential adverse effects include cytopenias (a reduction in the number of blood cells), liver enzyme elevation, pancreatitis, and bone marrow suppression. These side effects can be severe and may necessitate the cessation of treatment in some patients.

What prior FDA approvals exist?

As of now, there are no FDA-approved CAR T-cell therapies specifically targeting CD7 for T-Cell Lymphoma. The WU-CART-007 trial is exploring a novel approach with CD7-directed CAR T-cells that include CD7 and TRAC deletions to prevent fratricide and GvHD. Current FDA-approved CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, target CD19 and are used primarily for B-cell malignancies. These therapies have shown promise in treating relapsed or refractory lymphomas but are not specifically designed for T-Cell Lymphoma.

What other types of research exist?

Promising alternatives to WU-CART-007 for T-Cell Lymphoma patients include: 1) Bispecific T cell engagers (BiTEs) such as talquetamab (targeting GPRC5D and CD3) and cevostamab (targeting FcRH5 and CD3), which redirect T-cells to target cancer cells. 2) Agents targeting novel pathways, such as dinaciclib (a cyclin-dependent kinase inhibitor) and filanesib (a kinesin spindle protein inhibitor). 3) Other CAR T-cell therapies targeting different antigens, such as those directed against CD19 or BCMA, though primarily used in B-cell malignancies, they represent a platform for potential adaptation to T-cell targets.

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CAR T-cell Therapy

WU-CART-007 for Blood Cancers

Phase 1

Waitlist Available

Led By Peter Westervelt, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Permissible T-cell NHL subtypes include specific types

Patients with susceptible FLT3, IDH1, or IDH2 mutation should be resistant or intolerant to an agent targeting the specific mutation

Must not have

Confirmed HIV infection

Symptomatic, uncontrolled hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests WU-CART-007, a modified T-cell therapy, for patients with difficult-to-treat blood cancers. The therapy aims to specifically target and destroy cancer cells without causing harmful side effects. WU-CART-007 has shown potential in treating these types of cancers.

Who is the study for?

Adults with certain blood cancers like T-cell lymphoma or acute myeloid leukemia (AML) that have come back or didn't respond to treatment can join. They must have CD7+ cancer cells, be in good physical condition, and not pregnant. They need proper organ function and no other effective treatments available.

What is being tested?

The trial is testing WU-CART-007, a new type of CAR T-cell therapy for blood cancers expressing CD7. It's designed to avoid killing itself (fratricide-resistant) and prevent Graft-versus-Host-Disease by lacking certain cell receptors.

What are the potential side effects?

Potential side effects may include immune system reactions, symptoms from low blood counts due to bone marrow suppression, fatigue, fever, and risk of infection. Specific side effects related to this novel therapy are monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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My T-cell NHL is one of the allowed types.

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I am resistant or intolerant to treatments for my FLT3, IDH1, or IDH2 mutation.

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My cancer is a type of T-cell lymphoma or AML, not responding to treatment and tests positive for CD7.

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My T-cell non-Hodgkin lymphoma has come back or is not responding to treatment.

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My leukemia has returned or is not responding to treatment.

Exclusion Criteria

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

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I am HIV positive.

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I have low blood pressure that causes symptoms and is not under control.

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I have had a bone marrow transplant from a donor.

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I have Hepatitis B or C without having received a cure.

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I have not received T-cell targeting therapy within the last 8 weeks.

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I am currently receiving treatment for another type of cancer.

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I do not have a serious infection or condition that could worsen with treatment.

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I have never been treated with anti-CD7 therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 24 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with complete metabolic response or partial metabolic response (Part B only - Cohort A)

Number of participants with complete remission, complete remission with incomplete blood count recovery, complete remission with partial hematologic recovery, or morphologic leukemia free state (Part B only - Cohort B)

Recommended phase II dose (Part A only)

Secondary study objectives

Duration of remission (DoR)

Event-free survival (EFS)

Number of participants with cytokine release syndrome

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part B Cohort B: Dose Expansion WU-CART-007 AMLExperimental Treatment1 Intervention

Patients will receive preparative lymphodepletion in the week prior to WU-CART-007, after which WU-CART-007 will be infused 3 days following the last dose of chemotherapy at the recommended phase II dose.

Group II: Part B Cohort A: Dose Expansion WU-CART-007 T-NHLExperimental Treatment1 Intervention

Group III: Part A Cohort B: Dose Escalation WU-CART-007 AMLExperimental Treatment1 Intervention

Patients will receive preparative lymphodepletion in the week prior to WU-CART-007, after which WU-CART-007 will be infused 3 days following the last dose of chemotherapy at the assigned dose level.

Group IV: Part A Cohort A: Dose Escalation WU-CART-007 T-NHLExperimental Treatment1 Intervention

Patients will receive preparative lymphodepletion in the week prior to WU-CART-007, after which WU-CART-007 will be infused 3 days following the last dose of chemotherapy at the assigned dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

WU-CART-007

2022

Completed Phase 2

~30

0 / 13Eligibility 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

The most common treatments for T-Cell Lymphoma include chemotherapy, immunotherapy, and targeted therapies such as CAR T-cell therapy. Specifically, CD7-directed CAR T-cell therapy, like WU-CART-007, involves genetically modifying T-cells to target CD7, a marker found on malignant T-cells. This therapy includes deleting CD7 to prevent the CAR T-cells from killing each other (fratricide) and deleting TRAC to prevent Graft-versus-Host Disease (GvHD). These modifications are crucial as they enhance the safety and efficacy of the treatment, offering a promising option for patients with T-Cell Lymphoma who have limited treatment choices.