CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma.

Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.

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.

Inclusion Criteria:

• Classic Hodgkin lymphoma:

  • Relapsed patients after autologous hematopoietic stem cell transplantation who have already received Brentuximab-Vedotin and anti-PDL1 antibodies, OR
  • Primarily refractory patients who do not reach CR after rescue, including Brentuximab-Vedotin and anti-PDL1 antibodies.

• Anaplastic large T-cell lymphoma (ALK+/ALK-) and peripheral T-cell lymphoma (NOS/Angioimmunoblastic):

  • >90% of tumor cells expressing CD30 determined by immunohistochemistry, AND
  • Relapsed patients after autologous hematopoietic stem cell transplantation, OR
  • Primarily refractory patients (after first line, including anthracycline) who do not achieve CR after rescue.
  • All patients must sign an informed consent before starting any procedure.
  • All patients must have measurable disease (detected by PET-CT) at the time of inclusion.
  • Performance status: ECOG 0-1
  • FEV1> 39%; DLCO and FVC> 39% of NV.
  • No significant ventricular dysfunction: EF >45%.
  • Total bilirubin and transaminases <3 times the maximum normal value, unless attributable to lymphoma.
  • Creatinine <2 times the normal maximum value and clearance> 40 mL/min.

Exclusion Criteria:

• Performance status: ECOG 2-4
• Prior allogeneic haematopoietic stem cell transplant.
• Active hepatitis B, C or HIV infection
• Active bacterial, fungal, or viral infection.
• Evidence of CNS involvement by lymphoma.