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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)

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment125 people
  • Recruiting US sites16
  • SponsorAllotera Therapeutics
  • RegistryNCT06514794

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

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 one-minute explainerNCT065147941 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age6 Months to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

allogeneic anti-CD7 CAR T cells WU-CART-007. A preparation of off-the-shelf (OTS) donor-derived T lymphocytes that have been genetically engineered to express a chimeric antigen receptor (CAR) directed against the tumor-associated antigen (TAA) CD7, with potential immunostimulating and antineoplastic activities. Upon intravenous administration, the allogeneic anti-CD7 CAR T cells WU-CART-007 specifically recognize and bind to CD7-expressing tumor cells, resulting in specific T-cell-mediated tumor cell lysis. CD7 is a transmembrane glycoprotein expressed by T cells and natural killer (NK) cells and their precursors. It is expressed in the majority of lymphoblastic T-cell leukemias and lymphomas and in a subset of peripheral T-cell lymphomas. NCI Drug Dictionary

Treatments listed in the registry

  • WU-CART-007 (Biological): A single IV infusion of WU-CART-007

The study

Treatment groups

Na · Single Group · masking: None

WU-CART-007 (Experimental)

A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion

Goals

What the study measures

Main goals

  • R/R Cohort - Composite Complete Response Rate (24 months)
  • MRD Pos Cohort - Response Rate (24 months)

Planned enrollment: 125 (estimated).

Where

Recruiting US sites

  • City of Hope, Duarte, California
  • Children's Hospital Los Angeles, Los Angeles, California
  • Colorado Blood Cancer Institute, Denver, Colorado
  • Children's National Hospital, Washington D.C., District of Columbia
  • H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, Florida
  • Children's Hospital of Atlanta, Atlanta, Georgia
  • Washington University Saint Louis, St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center -- Pediatrics, New York, New York
  • Oncology Hematology Care, Cincinnati, Ohio
  • Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy, Nashville, Tennessee
  • MD Anderson Cancer Center, Houston, Texas
  • Sarah Cannon Transplant and Cellular Therapy Methodist Hospital, San Antonio, Texas
  • Sarah Cannon, Virginia Oncology Associates, Norfolk, Virginia
  • Seattle Children's Hospital, Seattle, Washington

2 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 27, 2026. Public record; not medical advice.

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