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CAR T-cell Therapy

WU-CART-007 for Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Wugen, Inc.

Eligibility Criteria Checklist

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

Must have

- There must be histological confirmation of relapse after HSCT of T-ALL or T-LBL.

Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification with bone marrow with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma in patients who have not responded to other treatments.

Who is the study for?

This trial is for patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL). Participants must have adequate organ function, a life expectancy over 12 weeks, and be at least 12 years old. They can't join if they've had certain previous treatments, active infections like hepatitis B/C or HIV, serious GvHD requiring systemic steroids, or are pregnant.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of WU-CART-007 CAR-T cells in treating T-ALL/LBL that has come back after treatment or hasn't responded to therapy. It aims to find the best dose and see how well it works against these cancers.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms, effects on blood counts leading to increased infection risk, fatigue, and possible impact on liver and kidney functions. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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My cancer returned after a stem cell transplant for T-cell leukemia or lymphoma.

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My T-ALL or T-LBL cancer has returned or is not responding to treatment, with signs of it in my bone marrow or outside the bone marrow.

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I haven't taken any immunosuppressive drugs for at least 2 weeks, except for low-dose steroids.

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I am mostly active and can carry out daily activities without significant help.

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My condition worsened or didn't improve after a stem cell transplant.

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My cancer did not fully respond to the first chemotherapy.

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I understand the study and agree to follow its rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

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

Composite Complete Response Rate

Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Duration of Response

Hematopoietic Stem Cell Transplant (HSCT) rate

Objective Response Rate

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: WU-CART-007Experimental Treatment1 Intervention

A CD7-directed chimeric antigen receptor (CAR) T-cell product. A single IV infusion of WU-CART-007 Cells on Day 1 after Lymphodepletion(LD) Therapy.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wugen, Inc.Lead Sponsor

5 Previous Clinical Trials

152 Total Patients Enrolled

Ken Jacobs, MDStudy DirectorWugen, Inc.

1 Previous Clinical Trials

44 Total Patients Enrolled

Jan Davidson, MDStudy DirectorWugen, Inc.

Media Library

WU-CART-007 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04984356 — Phase 1 & 2

Lymphoblastic Lymphoma Research Study Groups: WU-CART-007

Lymphoblastic Lymphoma Clinical Trial 2023: WU-CART-007 Highlights & Side Effects. Trial Name: NCT04984356 — Phase 1 & 2

WU-CART-007 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984356 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment currently accepting participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical study is actively recruiting patients after first being published on January 14th 2022 and most recently edited on October 6th 2022. This trial requires 44 volunteers across 8 distinct locations."

Answered by AI

How many subjects are partaking in this experiment?

"To complete the study, 44 individuals meeting certain requirements must enlist. Potential participants can be sourced from both Washington University in Saint Louis and Vanderbilt University in Nashville."

Answered by AI

Have any medical institutions in the U.S. launched this investigation?

"Various medical centres are recruiting for the clinical trial, including Washington University in Saint Louis, Vanderbilt University in Nashville and Children's Hospital of Philadelphia. Additionally, there are five additional sites engaging with patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

2022. "A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984356.