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

Phase 1

• Conditions: T Cell Lymphoma; Hodgkin Lymphoma, Adult

• Registration Number: NCT04653649
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-29
• Status Verified: 2020-11
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-30
• Last Update Submitted: 2020-11-30
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells	12 months	Number of patients with cytokine release syndrome and/or ICANs grade 1-4 according to ASBMT Consensus
To analyze the rate of complete responses at 3 months after the procedure	24 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.	12 months	Number of patients receiving maximum dose (1 x 10e7/kg CART+ cells) without DLT

Trial Locations

Locations (1)

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain