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

Primary Purpose

Hodgkin Lymphoma, Adult, T Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
HSP-CAR30
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma, Adult

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HSP-CAR30 (anti-CD30 CAR T cells)

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
To analyze the rate of complete responses at 3 months after the procedure

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
November 30, 2020
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Josep Carreras Leukaemia Research Institute, Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04653649
Brief Title
CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma.
Official Title
Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Josep Carreras Leukaemia Research Institute, Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Adult, T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSP-CAR30 (anti-CD30 CAR T cells)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
HSP-CAR30
Intervention Description
Anti-CD30 CAR T-cells
Primary Outcome Measure Information:
Title
To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
Description
Number of patients with cytokine release syndrome and/or ICANs grade 1-4 according to ASBMT Consensus
Time Frame
12 months
Title
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.
Description
Number of patients receiving maximum dose (1 x 10e7/kg CART+ cells) without DLT
Time Frame
12 months
Title
To analyze the rate of complete responses at 3 months after the procedure
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Briones, MD, PhD
Phone
+34935565649
Email
jbriones@santpau.cat
First Name & Middle Initial & Last Name & Degree
Ana Carolina Caballero, MD
Phone
+34935565649
Email
acaballero@santpau.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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