Hodgkin Lymphoma, Adult, T Cell Lymphoma
Conditions
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.
Interventions
BIOLOGICALHSP-CAR30
Anti-CD30 CAR T-cells
Sponsors
Josep Carreras Leukaemia Research Institute
Instituto de Salud Carlos III
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| To analyze the rate of complete responses at 3 months after the procedure | 24 months | — |
Countries
Spain
Outcome results
None listed