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

NCT04653649 | Unknown Phase 1 DMC

• 1 other identifier: IIBSP-CAR-2019-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma, Adult; T Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Biological: HSP-CAR30

Interventions

HSP-CAR30 BIOLOGICAL

Anti-CD30 CAR T-cells

HSP-CAR30 (anti-CD30 CAR T cells)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (1)

• Caballero AC, Ujaldon-Miro C, Pujol-Fernandez P, Montserrat-Torres R, Guardiola-Perello M, Escudero-Lopez E, Garcia-Cadenas I, Esquirol A, Martino R, Jara-Bustamante P, Ezquerra P, Soria JM, Iranzo E, Moreno-Martinez ME, Riba M, Sierra J, Alvarez-Fernandez C, Escriba-Garcia L, Briones J. HSP-CAR30 with a high proportion of less-differentiated T cells promotes durable responses in refractory CD30+ lymphoma. Blood. 2025 Apr 17;145(16):1788-1801. doi: 10.1182/blood.2024026758.

  PMID: 39841453 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental: HSP-CAR30 (anti-CD30 CAR T cells) Dose escalation phase: 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.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 4, 2020
• Study Start: September 29, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)