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.

Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma, Adult; T Cell Lymphoma
• Intervention / Treatment: Biological: HSP-CAR30

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital Santa Creu i Sant Pau
    • Contact: Javier Briones, MD, PhD; Phone Number: +34935565649; Email: jbriones@santpau.cat
    • Contact: Ana Carolina Caballero, MD; Phone Number: +34935565649; Email: acaballero@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSP-CAR30 (anti-CD30 CAR T cells); 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.	Biological: HSP-CAR30; Anti-CD30 CAR T-cells

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Instituto de Salud Carlos III; Josep Carreras Leukaemia Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: IIBSP-CAR-2019-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No