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

T Cell Lymphoma Clinical Trial

Official title:

Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653649
• Other study ID #: IIBSP-CAR-2019-30
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 29, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma
• Lymphoma, T-Cell
• T Cell Lymphoma

Intervention

Biological:
• HSP-CAR30
Anti-CD30 CAR T-cells

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Instituto de Salud Carlos III, Josep Carreras Leukaemia Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	To analyze the rate of complete responses at 3 months after the procedure		24 months