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DRUG:

SCRI-CARB7H3(s)

i
Other names: SCRI-CARB7H3(s) , second generation 4-1BBζ B7H3-EGFRt-DHFR , Autologous CD4+ and CD8+ T-cells genetically modified to express an B7H3-specific CAR, B7H3-specific CAR
Company:
Cellevolve Bio, Seattle Children's Hospital, Seattle Children’s Therapeutics
Drug class:
B7-H3-targeted CAR-T immunotherapy
over1year
STRIvE-02: B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults (clinicaltrials.gov)
P1, N=68, Active, not recruiting, Seattle Children's Hospital | Recruiting --> Active, not recruiting
Enrollment closed • CAR T-Cell Therapy
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CD276 (CD276 Molecule)
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CD276 expression • CD19 expression
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Keytruda (pembrolizumab) • SCRI-CARB7H3(s) • SCRI-CARB7H3(s)x19
over2years
STRIVE-02: A first-in-human phase 1 trial of systemic B7H3 CAR T cells for children and young adults with relapsed/refractory solid tumors. (ASCO 2022)
CYA patients with R/RST were enrolled onto a Phase 1 trial (NCT04483778) to examine the safety of autologous T cells genetically modified to express scFV-IgG4hinge-CD28tm-4-1BB-zeta B7H3-specific CAR with the methotrexate resistance/selection cassette DHFRdm and the tracking/suicide construct EGFRt. All patients received lymphodepleting fludarabine and cyclophosphamide prior to infusion of cryopreserved CAR-T at the prescribed dose level... B7H3 CAR T cells are safe and demonstrate anti-tumor activity in CYA with R/RST. CAR-T cell expansion and persistence may be necessary to achieve objective responses. STRIvE-02 Arm B will explore dual expression of CD19 CAR with B7H3 CAR, using lymphocytic CD19 expression to drive CAR expansion and persistence.
Clinical • P1 data • CAR T-Cell Therapy • IO biomarker
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CD19 (CD19 Molecule) • CD276 (CD276 Molecule)
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CD19 expression
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cyclophosphamide • methotrexate • fludarabine IV • SCRI-CARB7H3(s)