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CAR T-cell Therapy

WU-CART-007 for Blood Cancers

Phase 1

Recruiting

Led By Geoffrey Uy, M.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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing WU-CART-007 cells in patients with relapsed/refractory AML or T-NHL who have CD7 on the surface of their tumor cells.

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.Check my eligibility

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.See study design

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.

Select...

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

Select...

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

Select...

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

Select...

My leukemia has returned or is not responding to treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Duration of remission (DoR)

Event-free survival (EFS)

Number of participants with cytokine release syndrome

+4 more

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,756 Total Patients Enrolled

Wugen, Inc.Industry Sponsor

5 Previous Clinical Trials

142 Total Patients Enrolled

Geoffrey Uy, M.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

161 Total Patients Enrolled

Media Library

T-Cell Lymphoma Research Study Groups: Part A Cohort A: Dose Escalation WU-CART-007 T-NHL, Part A Cohort B: Dose Escalation WU-CART-007 AML, Part B Cohort A: Dose Expansion WU-CART-007 T-NHL, Part B Cohort B: Dose Expansion WU-CART-007 AML

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned WU-CART-007 for utilization?

"Our internal safety rating for WU-CART-007 is a 1, due to its being at the experimental stage of development with limited efficacy and safety data."

Answered by AI

Are there still vacancies available to join the investigation?

"This trial, which was initially posted on the 31st of December 2022 and last edited nearly a year later, is not actively searching for participants according to clinicaltrials.gov records. However, there are still 3136 other studies that are currently recruiting candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies

2023. "Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377827.

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