Clinical trial NCT04653649: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma, Adult
T Cell Lymphoma
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Josep Carreras Leukaemia Research Institute
name: Instituto de Salud Carlos III
First posted: 2020-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: To analyze the rate of complete responses at 3 months after the procedure
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
References: