Inmmunotherapy with peripheral blood, autologous, a dult T cells, expanded and transduced (gene modified) with a lentiviral vector expressing an anti-CD30-chimeric antigen receptor with 4-1-BB and CD3z costimulatory sequences in patients with Classical Hodgkin lymphoma and non-Hodgkin CD30+ T cell lymphoma.

Conditions

Refractary or relapse non-Hodgkin T CD30+ lymphoma., Refractary or relapse Hodgkin T CD30+ lymphoma

Brief summary

Dose-limiting toxicity (DLT): the proportion of patients with DLT in the first month after infusion of HSP-CAR30 cells will be calculated, for each dose, together with the 95% confidence interval., Safety: Data on the type and frequency of AEs will be collected for each dose level, starting from the infusion of HSP-CAR30 cells and up to 30 days thereafter., Answer: the percentage of responses (RC, RP and RG) will be analyzed according to RECIL 2017 criteria and its 95% confidence interval will be calculated. Only patients who receive the infusion of HSP-CAR30 cells will be evaluable for response. In no case will patients who do not present detectable disease by PET-CT (patient in CR), determined in the 30 days prior to the infusion of HSPCAR30 cells, be considered for response analysis.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFludarabina Accord 25 mg/ml concentrado para solución inyectable y para perfusión.

DRUGHSP-CAR30

DRUGLevact 2

DRUG5 mg/ml poudre pour solution à diluer pour perfusion

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGGenoxal 200 mg polvo para solución inyectable y para perfusión

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicity (DLT): the proportion of patients with DLT in the first month after infusion of HSP-CAR30 cells will be calculated, for each dose, together with the 95% confidence interval., Safety: Data on the type and frequency of AEs will be collected for each dose level, starting from the infusion of HSP-CAR30 cells and up to 30 days thereafter., Answer: the percentage of responses (RC, RP and RG) will be analyzed according to RECIL 2017 criteria and its 95% confidence interval will be calculated. Only patients who receive the infusion of HSP-CAR30 cells will be evaluable for response. In no case will patients who do not present detectable disease by PET-CT (patient in CR), determined in the 30 days prior to the infusion of HSPCAR30 cells, be considered for response analysis.	—

Measure

Time frame

Dose-limiting toxicity (DLT): the proportion of patients with DLT in the first month after infusion of HSP-CAR30 cells will be calculated, for each dose, together with the 95% confidence interval., Safety: Data on the type and frequency of AEs will be collected for each dose level, starting from the infusion of HSP-CAR30 cells and up to 30 days thereafter., Answer: the percentage of responses (RC, RP and RG) will be analyzed according to RECIL 2017 criteria and its 95% confidence interval will be calculated. Only patients who receive the infusion of HSP-CAR30 cells will be evaluable for response. In no case will patients who do not present detectable disease by PET-CT (patient in CR), determined in the 30 days prior to the infusion of HSPCAR30 cells, be considered for response analysis.

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Countries

Spain

Outcome results

None listed