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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma, Adult; T Cell Lymphoma

Treatments: Biological: HSP-CAR30

Study type: Interventional

Funder types: Other

Identifiers

NCT04653649

IIBSP-CAR-2019-30

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HSP-CAR30 (anti-CD30 CAR T cells)

Experimental group

Description:

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.

Treatment:

Biological: HSP-CAR30