CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma.
NCT ID: NCT04653649
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2020-09-29
2023-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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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.
HSP-CAR30
Anti-CD30 CAR T-cells
Interventions
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HSP-CAR30
Anti-CD30 CAR T-cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Josep Carreras Leukaemia Research Institute
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Facility Contacts
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Javier Briones, MD, PhD
Role: primary
Ana Carolina Caballero, MD
Role: backup
References
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Caballero AC, Ujaldon-Miro C, Pujol-Fernandez P, Montserrat-Torres R, Guardiola-Perello M, Escudero-Lopez E, Garcia-Cadenas I, Esquirol A, Martino R, Jara-Bustamante P, Ezquerra P, Soria JM, Iranzo E, Moreno-Martinez ME, Riba M, Sierra J, Alvarez-Fernandez C, Escriba-Garcia L, Briones J. HSP-CAR30 with a high proportion of less-differentiated T cells promotes durable responses in refractory CD30+ lymphoma. Blood. 2025 Apr 17;145(16):1788-1801. doi: 10.1182/blood.2024026758.
Other Identifiers
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IIBSP-CAR-2019-30
Identifier Type: -
Identifier Source: org_study_id