Clinical trial · Interventional
CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma.
Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.
NCT04653649CI-TRIAL-00048644unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma, Adult | Adult Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| T Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSP-CAR30 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSP-CAR30 (anti-CD30 CAR T cells)
- 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.
- interventionNames
- Biological: HSP-CAR30
Primary outcomes (3)
- measure
- To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells
- timeFrame
- 12 months
- description
- Number of patients with cytokine release syndrome and/or ICANs grade 1-4 according to ASBMT Consensus
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCaballero 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. PMID 39841453