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Phase 2 Study of WU-CART-007 for T-Cell Leukemia and Lymphoma

This study is testing a new treatment called WU-CART-007, a type of cell therapy, for people with T-cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoblastic Lymphoma (T-LBL). These are cancers that affect certain white blood cells. You might be able to join if your cancer has come back or hasn't responded to previous treatments (relapsed/refractory), or if you are in remission but still have a small amount of cancer cells (MRD positive). The study aims to see how many people have a complete response to WU-CART-007, meaning their cancer goes away, or if it can make the cancer undetectable. The study plans to enroll about 125 participants, but its current recruitment status is unclear.

Study design
This is a Phase 2, single-arm study, meaning everyone receives the same treatment, WU-CART-007. It is also open-label, so both you and your doctors will know what treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your response to treatment for up to 24 months after receiving WU-CART-007.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06514794

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)

Recruiting
PHASE2Ages 1+InterventionalTreatment
Allotera Therapeutics
~125 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:WU-CART-007

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
R/R Cohort - Composite Complete Response Rate
Measured over 24 months
+1 more outcome measured

Conditions

T-cell Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma

Explore related trials

Lymphoblastic LymphomaPre T-ALL

Where it's being run

17 sites across 13 states
California2
Ohio2
Texas2
Victoria2
Colorado1
District of Columbia1
Florida1
Georgia1

Study leadership

  • Cherry Thomas, MD · STUDY_DIRECTOR · Allotera Therapeutics

Who to contact

Wugen Clinical Trials
[email protected]
314-501-1968
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • R/R Cohort - Composite Complete Response Rate24 months

    CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)

  • MRD Pos Cohort - Response Rate24 months

    Defined as the efficacy of WU-CART-007 to induce complete MRD negative response