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RecruitingPhase 2

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Months and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests WU-CART-007, a CAR-T treatment that uses donor immune cells to fight cancer. It is for people with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) that came back, did not respond to treatment, or still has small amounts of cancer after treatment. The study aims to see if treatment can leave no cancer found by very sensitive tests.

The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have T-ALL or T-LBL that came back, did not respond to treatment, or still has small amounts of cancer after treatment.
  • Be at least 6 months old.
  • Have organs that work well enough.
  • Meet activity score limits at screening: ECOG 0 or 1, or Karnofsky 70 or higher. These scores measure how well you can do daily tasks.

Who can't join

  • Have had treatment that targets CD7 before.
  • Have hemolytic anemia that the body cannot keep up with, meaning red blood cells are destroyed too fast.
  • Have grade 2–4 acute or extensive long-term graft-versus-host disease (GvHD) that needs medicine to lower immune activity throughout the body. GvHD is when donor cells attack your body. Grade 1 without such medicine, or grade 2 affecting only the skin and treated only with skin medicine, is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive * Age: Lower age limit of ≥ 6 months; adequate organ function * Eastern Cooperative Oncology Group (ECOG) 0 or 1/Karnofsky Performance Status 70 and above at Screening. Key Exclusion Criteria: * Prior treatment with any anti-CD7 therapy. * Patients with decompensated hemolytic anemia. * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.

Study sites (16)

CA

CO

  • Colorado Blood Cancer Institute · Denver, CO 80218Alireza Eghtedar, M.D. · Principal investigatorMore trials in Denver

DC

FL

GA

MO

NY

OH

PA

TN

TX

VA

WA

  • Seattle Children's Hospital · Seattle, WA 98105Adam Lamble, M.D. · Principal investigatorMore trials in Seattle