HSP-CAR30 is a cell suspension of genetically modified T-cells to express a second generation (4-1BBz) chimeric antigen receptor (CAR) directed against CD30. This is a phase I/IIa, interventional, single arm, open label, treatment study to evaluate the safety, tolerability and efficacy of HSP-CAR30 in patients with relapsed/refractory Hodgkin lymphoma and relapsed/refractory T-cell lymphoma expressing CD30.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anti-CD30 CAR T-cells
Hospital Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGTo assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
Number of patients with cytokine release syndrome and/or ICANs grade 1-4 according to ASBMT Consensus
Time frame: 12 months
To establish the maximum tolerated dose (MTD; defined as the dose that induces maximum limiting toxicity) of autologous anti-CD30 CAR T-cells in patients with refractory or relapsed classic Hodgkin or CD30 + T NHL.
Number of patients receiving maximum dose (1 x 10e7/kg CART+ cells) without DLT
Time frame: 12 months
To analyze the rate of complete responses at 3 months after the procedure
Time frame: 24 months
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