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WU-CART-007 anti-CD7 CAR-T for relapsed or MRD-positive T-cell ALL and lymphoblastic lymphoma

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)

Phase 2 Interventional Wugen, Inc. · NCT06514794

This trial will try WU-CART-007, an off-the-shelf anti-CD7 CAR-T therapy, in people with relapsed/refractory or MRD-positive T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma to see if it produces MRD-negative remissions.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment125 (estimated)
Ages1 Year and up
SexAll
SponsorWugen, Inc. Industry-sponsored
Drugs / interventionsCART
Locations15 sites (Duarte, California and 14 other locations)
Trial IDNCT06514794 on ClinicalTrials.gov

What this trial studies

WU-CART-007 is an allogeneic anti-CD7 CAR-T cell therapy designed to target T-cell malignancies. This Phase 2, single-arm, multi-center, open-label trial enrolls patients aged six months and older with relapsed/refractory T-ALL or T-LBL or those in remission but remaining MRD positive. Participants receive a WU-CART-007 infusion at one of the study centers and are followed for response, MRD status, durability of remission, and safety, including CAR-T–related toxicities and graft-versus-host disease. The primary goal is to see how often the therapy induces complete MRD-negative remissions, with secondary endpoints focused on durability and adverse events.

Who should consider this trial

Good fit: Ideal candidates are people aged six months or older with relapsed/refractory T-ALL or T-LBL, or those in remission but still MRD-positive, who have adequate organ function and good performance status.

Not a fit: Patients who previously received anti-CD7 therapy, have decompensated hemolytic anemia, or have active grade 2–4 graft-versus-host disease requiring systemic immunosuppression are unlikely to be eligible or benefit from this therapy.

Why it matters

Potential benefit: If successful, WU-CART-007 could produce deep MRD-negative remissions and provide a new treatment option for patients with relapsed or MRD-positive T-cell ALL/LBL.

How similar studies have performed: Early-phase reports of anti-CD7 CAR-T approaches have shown promising responses in T-cell malignancies, but larger confirmatory trials remain limited.

Eligibility criteria

Show full inclusion / exclusion 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)/Karnofsky Performance Status 0 or 1/70 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.

Where this trial is running

Duarte, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions T-cell Acute Lymphoblastic LeukemiaLymphoblastic LymphomaCAR-T Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.