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)

Part of paid clinical trials in Duarte, California.

Sponsor
Wugen, Inc.
Study ID
NCT06514794
Phase
PHASE2
Status
Recruiting

Conditions

  • Lymphoblastic Lymphoma
  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • WU-CART-007 — BIOLOGICAL
    A single IV infusion of WU-CART-007

Study Details

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

Key Dates

Start date
Jan 31, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: WU-CART-007
    A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion

Primary Outcome Measure

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

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Ibrahim Aldoss, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital Los AngelesLos AngelesCalifornia90027
Angela Kang
323-361-2121
Amber Medina
(323) 361-5654
Deepa Bhojwani, MD (PRINCIPAL_INVESTIGATOR)
Colorado Blood Cancer InstituteDenverColorado80218
Alireza Eghtedar, M.D. (PRINCIPAL_INVESTIGATOR)
H. Lee Moffitt Cancer Center and Research Institute HospitalTampaFlorida33612
Garrett Welch
Rawan Faramand, M.D. (PRINCIPAL_INVESTIGATOR)
Washington University Saint LouisSt LouisMissouri63108
Katie Stricker
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jeremy Rubinstein, MD
Oncology Hematology CareCincinnatiOhio45226
Doug Hart
513-751-2273
Ahmed Galal, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19390
Brooke Leibfreid
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular TherapyNashvilleTennessee37203
Stephen Strickland, M.D. (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Elias Jabbour, M.D. (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Transplant and Cellular Therapy Methodist HospitalSan AntonioTexas78229
Christian Herrera
210-575-6026
Nosha Farhadfar, M.D. (PRINCIPAL_INVESTIGATOR)
Sarah Cannon, Virginia Oncology AssociatesNorfolkVirginia23502
Wendi Gobhardt
757-213-5813
Gary L. Simmons, D.O. (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Adam Lamble, M.D. (PRINCIPAL_INVESTIGATOR)

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