Trial | NCT04653649  Report issue

Title

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.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    30
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 Started
Sep 29
2020
Primary Completion
Dec 30
2023
Anticipated
Study Completion
Dec 30
2023
Anticipated
Last Update
Dec 04
2020

Biological HSP-CAR30

Anti-CD30 CAR T-cells

HSP-CAR30 (anti-CD30 CAR T cells) Experimental

Phase I: Ten patients will be treated with HSP-CAR30 (anti-CD30 CAR T-cells) with an escalation approach to define maximum tolerated dose (MTD) from 3 x 106/kg to 10 x 106/kg. Phase IIa: Twenty patients will be treated with HSP-CAR30 at MTD to evaluate efficacy.

Criteria 

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.
No Results Posted