Combined results from two Phase 1/2 trials in the Journal of Clinical Oncology led by Baylor college of medicine and the University of North Carolina Lineberger comprehensive cancer center
Based on these results Tessa has registered a pivotal Phase 2 trial (R/R CD30+ classical Hodgkin Lymphoma), expected to initiate in Q4’20
Patients received TT11 CAR-T after fludarabine-based lymphodepletion
Trial details and results:
A Phase 1b/2 to establish a safe dose of T Lymphocytes expressing the CD30.CAR for R/R CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma (N=40)
A Phase 1 study of relapsed CD30 expressing lymphoma treated with CD30.CAR-T cells to learn more about the way the CD30.CAR-T cells are working and how long they last in the body (N=66)
Efficacy:
ORR: 72% (in 32 patients), Complete response: 59% (19 patients)
1-year PFS: 36% (95% CI, 21% to 51%); OS: 94% (95% CI, 79% to 99%)
Safety:
Cytokine release syndrome: 10 patients (grade 1)
Most common toxicities: Grade 3 or higher hematologic adverse events
Tessa Therapeutics shows positive Phase 1/2 data for autologous CD30 CAR-T cell therapy in R/R, HL
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CI Scientists Remarks:
CD30 is a validated target of classical Hodgkin lymphoma and some non-Hodgkin lymphomas. The CD30-targeting CAR enables the recognition and elimination of CD30+ lymphoma cells
Tessa is collaborating with Baylor college of medicine to develop CAR-Ts since 2016
Tessa Therapeutics has access to patents and data from both the trials
Based on these results, the US FDA has granted CD30 CAR-T Cell Therapy Regenerative Medicine Advanced Therapy (RMAT) Designation for the treatment of R/R CD30+ classical Hodgkin Lymphoma
Tessa Therapeutics is exploring the potential of CD30.CAR-T therapy in CD30+ expressing non-Hodgkin lymphomas and CD30+ lymphomas and HER2 targeting CAR-T (HER2+ solid tumors)