WU-CART-007 anti-CD7 CAR-T for relapsed or MRD-positive T-cell ALL and lymphoblastic lymphoma
Official title: 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)
Run by Allotera Therapeutics · NCT06514794 · Data updated 2026-11-12
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months and up |
| Sex | All |
| Enrollment | 125 (estimated) |
| Sponsor | Allotera Therapeutics Industry-sponsored |
| Drugs / interventions | CART |
| Locations | 18 sites (Duarte, California and 17 other locations) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06514794 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Early-phase reports of anti-CD7 CAR-T approaches have shown promising responses in T-cell malignancies, but larger confirmatory trials remain limited.
Who can join: the full rules
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) 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.
Where it's running
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City of Hope
Duarte, California, United States Recruiting -
Children's Hospital Los Angeles
Los Angeles, California, United States Recruiting -
Colorado Blood Cancer Institute
Denver, Colorado, United States Recruiting -
Children's National Hospital
Washington D.C., District of Columbia, United States Recruiting -
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States Recruiting -
Children's Hospital of Atlanta
Atlanta, Georgia, United States Recruiting
Show 12 more locations
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Washington University Saint Louis
St Louis, Missouri, United States Recruiting -
Memorial Sloan Kettering Cancer Center -- Pediatrics
New York, New York, United States Recruiting -
Oncology Hematology Care
Cincinnati, Ohio, United States Recruiting -
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting -
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
Nashville, Tennessee, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
San Antonio, Texas, United States Recruiting -
Sarah Cannon, Virginia Oncology Associates
Norfolk, Virginia, United States Recruiting -
Seattle Children's Hospital
Seattle, Washington, United States Recruiting -
Peter Mac Callum Cancer Institute
Melbourne, Victoria, Australia Recruiting -
Royal Children's Melbourne
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Allotera Therapeutics Clinical Trials Clinical Trials
- Email: clinicaltrials@alloteratx.com
- Phone: 314-501-1968
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.