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Hodgkin Lymphoma, AdultPhase 1/2NCT04653649

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

A Phase 1/2 study testing HSP-CAR30 in people with Hodgkin Lymphoma, Adult and T Cell Lymphoma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hodgkin Lymphoma, Adult, T Cell Lymphoma
What is being tested?
HSP-CAR30
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
29 Sep 2020to 30 Dec 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

    Javier Briones, MD, PhD, +34935565649, jbriones@santpau.cat

    Ana Carolina Caballero, MD, +34935565649, acaballero@santpau.cat

    Recruiting

Other trials in Spain

About this study

Official title: Immunotherapy With Autologous CAR30 T Cells for Patients With Classic Hodgkin Lymphoma and Non-Hodgkin T-cell Lymphoma With CD30 Expression.

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.

Being tested
HSP-CAR30
Medical subject headings
Hodgkin Disease, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSP-CAR30Biological

    Anti-CD30 CAR T-cells

Study groups in NCT04653649
Study groupRoleWhat they receive
HSP-CAR30 (anti-CD30 CAR T cells)ExperimentalPhase 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.
Receives: Biological: HSP-CAR30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start29 Sep 2020
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653649
Sponsor's protocol ID
IIBSP-CAR-2019-30
Status last verified
Nov 2020
First submitted
18 Nov 2020
Last updated
4 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39841453

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HSP-CAR30 in people with Hodgkin Lymphoma, Adult and T Cell Lymphoma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess safety and toxicity of the administration of autologous anti-CD30 CAR T-cells (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04653649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.

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