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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)

RECRUITINGPhase 2Sponsored by Allotera Therapeutics
Actively Recruiting
PhasePhase 2
SponsorAllotera Therapeutics
Started2025-01-31
Est. completion2026-12-30
Eligibility
Age6 Months+
Healthy vol.Accepted
Locations16 sites

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

Eligibility

Age: 6 Months+Healthy volunteers 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.

Conditions3

CancerLymphoblastic LymphomaT-cell Acute Lymphoblastic Leukemia

Interventions1

Locations16 sites

City of Hope
Duarte, California, 91010
Children's Hospital Los Angeles
Amneh Aljazzar323-361-4156aaljazzar@chla.usc.edu
Colorado Blood Cancer Institute
Alireza Eghtedar, M.D.
Children's National Hospital
Washington D.C., District of Columbia, 20010
Mallika Khanna202-476-8938mkhanna1@childrensnational.org
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612

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