ClinicalTrials.gg
RecruitingNCT06514794Updated Sep 28, 2026

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 interventional study of WU-CART-007 in T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by Allotera Therapeutics. Recruiting at 18 sites in 2 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Allotera Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Updated Sep 28, 2026Eligibility revisedGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
6 Months and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 285 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in United States — 25 open to participants now, 38 under way, 3 of them phase 3. Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · United States.

Planned enrollment
21st of 230
125 · median 30
Started
2025
with 2 others
Phase 2
80 of 285
9 open now
Primary completion
2026-12
later than 14 of 36 live
Registered
275th of 285
by date

Among the 285 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in United States, this one is the 21st largest by planned enrollment of the 230 interventional ones that give a count, is one of 3 that started in 2025, is one of 80 in phase 2, reaches primary completion later than 14 of the 36 other live ones, and was the 275th registered.

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

420 studies on the registry are indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; 76 are open to participants now.

Browse Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies →

Open to participants now

25 of the 285 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in United States are open now. Recruiting first, the newest first:

19 more — sign in →

All 25 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 60 Precursor T-Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 24 (40%) set no upper age limit and 31 (52%) stop at 75 or younger; 36 take children under 18; 1 takes healthy volunteers.

This study: 6 Months and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 285 studies in Precursor T-Cell Lymphoblastic Leukemia-Lymphoma with a site in United States, or all of them as a file.
02

Study summary

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

Read the detailed description

This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

03

Conditions studied

  • T-cell Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma

Keywords

  • CAR-T Therapy
  • Acute Leukemia
04

Who can participate

The criteria were revised on the registry on Sep 28, 2026. See what changed

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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/ or MRD positive
  • Age: Lower age limit of ≥ 6 months; adequate organ function
  • (ECOG) 0 or 1/ 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 . Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    WU-CART-007

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

    Biological: WU-CART-007

Interventions

  • BiologicalWU-CART-007

    A single IV infusion of WU-CART-007

06

What researchers measure

Primary outcomes

  1. R/R Cohort - Composite Complete Response Rate

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

    Time frame: 24 months

  2. MRD Pos Cohort - Response Rate

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

    Time frame: 24 months

07

Study locations

18 of 18 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 22 months after the start.

Of 44 phase 2 interventional studies under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 97. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Jul 23, 2024
StartActual
Jan 31, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2028
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 criterion edited
What changed in the criteria
  • EditedEastern Cooperative Oncology Group (ECOG) 0 or 1/Karnofsky Performance Status 0 or 1/70 and above at Screening.
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Eligibility 1 criterion edited
    What changed in the criteria
    • EditedEastern Cooperative Oncology Group (ECOG) 0 or 1/Karnofsky Performance Status 0 or 1/70 and above at Screening.

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06514794
Lead sponsor
Allotera Therapeutics
Responsible party
Sponsor
First posted
Jul 23, 2024
Start date
Jan 31, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Allotera Therapeutics Clinical Trials Clinical Trials
Contact
clinicaltrials@alloteratx.com
314-501-1968
Cherry Thomas, MD
study director · Allotera Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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