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

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04653649
• Collaborator: Josep Carreras Leukaemia Research Institute (Other), Instituto de Salud Carlos III (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma, Adult; T Cell Lymphoma	Biological: HSP-CAR30	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.
• Actual Study Start Date: Sep 29, 2020
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. To analyze the rate of complete responses at 3 months after the procedure [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Santa Creu i Sant Pau	Barcelona		Spain	08041

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT04653649
• Other Study ID Numbers: IIBSP-CAR-2019-30
• First Posted: Dec 4, 2020
• Last Update Posted: Dec 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Dec 4, 2020