Recruiting

Phase 2

WU-CART-007A 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)

Sponsor:

Allotera Therapeutics

Code:

NCT06514794

Conditions

T-cell Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

WU-CART-007

Study Details

Brief 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

Conditions

T-cell Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Study ID

NCT06514794

Start date

Jan 31, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: WU-CART-007

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

Lymphodepletion

Interventions

WU-CART-007

A single IV infusion of WU-CART-007

Primary outcome measure

R/R Cohort - Composite Complete Response Rate [ Time Frame: 24 months ]
MRD Pos Cohort - Response Rate [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Allotera Therapeutics Clinical Trials Clinical Trials

314-501-1968 clinicaltrials@alloteratx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

tolaitan@coh.org

Principal Investigator:

Ibrahim Aldoss, MD

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Amneh Aljazzar

323-361-4156 aaljazzar@chla.usc.edu

Amber Medina

(323) 361-5654 ammedina@chla.usc.edu

Principal Investigator:

Deepa Bhojwani, MD

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Alireza Eghtedar, M.D.

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Mallika Khanna

202-476-8938 mkhanna1@childrensnational.org

Principal Investigator:

Keri Toner, MD

H. Lee Moffitt Cancer Center and Research Institute Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Garrett Welch

Garrett.Welch@Moffitt.org

Principal Investigator:

Rawan Faramand, M.D.

Children's Hospital of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Judson Russell

404-433-6653 BMT@choa.org

Principal Investigator:

Muna Qayed, MD

Washington University Saint Louis

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Katie Stricker

kstricker@wustl.edu

Memorial Sloan Kettering Cancer Center -- Pediatrics

Recruiting

New York, New York, United States, 10017

Contacts

Ramzi Khalaf

khalafr@mskcc.org

Principal Investigator:

Kevin Curran, M.D.

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45226

Contacts

Doug Hart

513-751-2273 Doug.Hart@USOncology.com

Principal Investigator:

Ahmed Galal, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jeremy Rubinstein, MD

Jeremy.Rubinstein@cchmc.org

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19390

Contacts

Brooke Leibfreid

leibfreidb@chop.edu

TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

SCRI.DDUreferrals@scri.com

Principal Investigator:

Stephen Strickland, M.D.

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Elias Jabbour, M.D.

Sarah Cannon Transplant and Cellular Therapy Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Christian Herrera

210-575-6026 SCRI@Methodisttransplantinstitute.com

Principal Investigator:

Nosha Farhadfar, M.D.

Sarah Cannon, Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Wendi Gobhardt

757-213-5813 Wendi.Gobhardt@usoncology.com

Principal Investigator:

Gary L. Simmons, D.O.

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Principal Investigator:

Adam Lamble, M.D.

More Information

Sponsor

Allotera Therapeutics

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

CAR-T Therapy
Acute Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Allotera Therapeutics on 2026-09-03.