T-cell Acute Lymphoblastic LeukemiaPhase 2NCT06514794
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 study testing WU-CART-007 in people with T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Allotera Therapeutics at 18 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- What is being tested?
- WU-CART-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 31 Jan 2025to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Allotera Therapeutics Clinical Trials Clinical Trials contact
18 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
Children's Hospital of Atlanta
Atlanta, Georgia, 30329
Judson Russell, 404-433-6653, BMT@choa.org
Muna Qayed, MD
- Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45226
Doug Hart, 513-751-2273 ext. 22401, Doug.Hart@USOncology.com
Ahmed Galal, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jeremy Rubinstein, MD, Jeremy.Rubinstein@cchmc.org
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Alireza Eghtedar, M.D.
- Recruiting
City of Hope
Duarte, California, 91010
tolaitan@coh.org
Ibrahim Aldoss, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Elias Jabbour, M.D.
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Amneh Aljazzar, 323-361-4156, aaljazzar@chla.usc.edu
Amber Medina, (323) 361-5654, ammedina@chla.usc.edu
- Recruiting
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
Nashville, Tennessee, 37203
SCRI.DDUreferrals@scri.com
Stephen Strickland, M.D.
- Recruiting
Memorial Sloan Kettering Cancer Center -- Pediatrics
New York, New York, 10017
Ramzi Khalaf, khalafr@mskcc.org
Kevin Curran, M.D.
- Recruiting
Sarah Cannon, Virginia Oncology Associates
Norfolk, Virginia, 23502
Wendi Gobhardt, 757-213-5813, Wendi.Gobhardt@usoncology.com
Gary L. Simmons, D.O.
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19390
Brooke Leibfreid, leibfreidb@chop.edu
- Recruiting
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
San Antonio, Texas, 78229
Christian Herrera, 210-575-6026, SCRI@Methodisttransplantinstitute.com
Nosha Farhadfar, M.D.
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Adam Lamble, M.D.
- Recruiting
Washington University Saint Louis
St Louis, Missouri, 63108
Katie Stricker, kstricker@wustl.edu
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Garrett Welch, Garrett.Welch@Moffitt.org
Rawan Faramand, M.D.
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Mallika Khanna, 202-476-8938, mkhanna1@childrensnational.org
Keri Toner, MD
Australia2 sites, 2 recruiting
- Recruiting
Peter Mac Callum Cancer Institute
Melbourne, Victoria, 3000
Ashish Bajel, M.D., pcctu.haema@petermac.org
PCCTU HaemA
- Recruiting
Royal Children's Melbourne
Melbourne, Victoria, 3000
Seong Lin Khaw, M.D., clinicaltrialsmanager@rch.org.au
About this study
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)
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.
- Being tested
- WU-CART-007
- Keywords
- CAR-T Therapy, Acute Leukemia
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WU-CART-007Biological
A single IV infusion of WU-CART-007
| Study group | Role | What they receive |
|---|---|---|
| WU-CART-007 | Experimental | A CD7-directed chimeric antigen receptor (CAR) T-cell product.
Lymphodepletion Receives: Biological: WU-CART-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
MRD Pos Cohort - Response Rate
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start31 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is divided into 2 cohorts: Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allotera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cherry Thomas, MD, Study director, Allotera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514794
- Sponsor's protocol ID
- WUC007-03
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06514794
- Acronym / sponsor ID
- WUC007-03
- Keywords
- CAR-T Therapy, Acute Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Allotera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is divided into 2 cohorts: Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
| Arm | Type | Receives |
|---|---|---|
| WU-CART-007 | Experimental | Biological: WU-CART-007A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WU-CART-007A single IV infusion of WU-CART-007 | Biological | WU-CART-007 |
Primary outcome
R/R Cohort - Composite Complete Response Rate
Time frame: 24 months
CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
MRD Pos Cohort - Response Rate
Time frame: 24 months
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allotera Therapeutics Clinical Trials Clinical Trials contact
Cherry Thomas, MD study director
Allotera Therapeutics
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WU-CART-007 in people with T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Allotera Therapeutics at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allotera Therapeutics Clinical Trials Clinical Trials (314-501-1968, clinicaltrials@alloteratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R/R Cohort - Composite Complete Response Rate (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.