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Refractory B-Cell LymphomaPhase 1/2TranspoCART19NCT06378190

Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology

A Phase 1/2 study testing CAR-T cells therapy in people with Refractory B-Cell Lymphoma and B-cell Lymphoma Recurrent, run by Instituto de Investigación Biomédica de Salamanca at 8 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are: Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
CAR-T cells therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
8 sitesSpain
Study dates
11 Mar 2024to Jul 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with relapsed or refractory B-cell lymphoma (Diffuse large B-cell lymphoma, Primary diffuse large B-cell lymphoma of the Central Nervous System (CNS), Mantle cell lymphoma, Follicular lymphoma grades 1, 2 or 3a or Marginal lymphoma, including splenic, nodal and MALT).
  • Age over 18 years and under 80 years.
  • Functional status Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Patients with ECOG 2 may be included if motivated by haematological disease (Annex 3).
  • Adequate bone marrow haematopoietic reserve.
  • Life expectancy of at least 2 months.
  • Adequate venous access for lymphapheresis. Absence of contraindications for lymphapheresis.
  • Signed informed consent (patient or legal guardian).

Who cannot join

  • Patients who, in the opinion of a physician, may benefit from other approved potentially curative therapeutic options, including commercial CAR-Ts.
  • Treatment with any experimental or non-commercialised substance in the four weeks prior to recruitment, or who are actively participating in another therapeutic clinical trial.
  • Diagnosis of another neoplasm, past or present. Patients who have been in complete remission for more than 3 years, or with a history of non-melanoma skin cancer or completely resected carcinoma in situ may be included. A current or previous history of clonal T-lymphocytes is also an exclusion criterion.
  • Early relapse after allogeneic haematopoietic stem cell transplantation (less than 3 months for lymphapheresis, less than 6 months for TranspoCART19 infusion) or patients on active immunosuppressive treatment for graft-versus-recipient disease (corticosteroids or other systemic immunosuppressants).
  • Active infection requiring systemic medical treatment.
  • HIV infection.
Show all 16Show fewer
  • Concurrent and uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric illnesses that in the opinion of the investigator pose a risk to the patient.
  • Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBcore antibodies, a hepatitis B virus DNA test will be required, and if the result is positive the patient will be excluded.
  • Positive serology for hepatitis C virus (HCV), defined as a positive test for anti-HCV antibodies that is confirmed by Recombinant immunoblot assay (RIBA).
  • Severe organ involvement, defined as cardiac ejection fraction <40%; diffusing capacity of the lungs for carbon monoxide (DLCO) <40%; calculated glomerular filtration rate <30 ml/min; baseline O2 saturation <92%; bilirubin > 2 times upper limit of normal (unless due to Gilbert's syndrome) or transaminases > 2.5 upper limit of normal.
  • Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test at screening.
  • Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective methods of contraception* from the start of the study until the end of the study.
  • Men who are unable or unwilling to use highly effective methods of contraception* from the start of the study until the end of the study.
  • Need to take glucocorticoids chronically in doses greater than 10 mg/day of prednisone (or equivalent) or other chronic immunosuppressants.
  • Previous anti-CD19 CAR-T therapy. Previous treatment with other anti-CD19 strategies is permitted, provided that CD19 expression has been confirmed in the tumour biopsy.
  • Hypersensitivity to the active substance or to any of the excipients.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Esperanza López_Franco, PhD contact

923 291200 ext. 55779

uicec.coordinacion@ibsal.es

Fátima Macho Sánchez-Simón contact

923 291200 ext. 55779

uicec.admon@ibsal.es

8 sites in 1 country

Spain8 sites, 8 recruiting

  • Hospital Clínic

    Barcelona, Barcelona

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Nuria Martínez Cibrian

    Not yet recruiting

  • Virgen de la Arrixaca University Hospital

    El Palmar, Mur

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Joaquín Gómez-Espuch

    Recruiting

  • Institut Català d'Oncologia Hospital

    L'Hospitalet de Llobregat, Barcelona

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Alberto Musetti

    Recruiting

  • Fundación Jiménez Díaz Hospital

    Madrid, Madrid

    Esperanza López-Franco, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Javier Cornago-Navascués

    Recruiting

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Carlos Grande

    Recruiting

  • University Hospital of Navarra

    Pamplona, Navarre

    Esperanza López-Franco, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    María Carmen Mateos-Rodríguez

    Recruiting

  • Salamanca University Health Care Complex

    Salamanca, SALAMANCA, 37007

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    Lucía López-Corral, PhD

    Recruiting

  • Virgen del Rocio Hospital

    Seville, Sevilla

    Esperanza López-Franco, PhD, 923291200 ext. 55779, uicec.coordinacion@ibsal.es

    José Antonio Pérez-Simón

    Recruiting

Other trials in Spain

About this study

Official title: Multicentre Phase I/IIa Study of Infusion of Autologous Peripheral Blood T Lymphocytes Expanded and Genetically Modified Using Sleeping Beauty Family Transposons to Express a Chimeric Antigenic Receptor With Anti-CD19 Specificity Conjugated to the 4-1BB Co-stimulatory Region and CD3z and huEGFRt Signal Transmission (TranspoCART19) in Patients With Relapsed or Refractory B-cell Lymphoma

The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:

Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.

Read the detailed description

This clinical trial is a Phase I/II, pilot, open-label, national, prospective, multicentre, non-randomised, open-label study to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma whose prognosis is less than 2 years.

Phase I: Dose escalation phase with a classic 3+3 design, in which three dose levels of TranspoCART19 will be evaluated: 1 x 106 cells/kg, 3 x106 cells/kg and 5 x 106 cells/kg. The maximum number of patients included in this phase will be 18.

Phase II: an expansion cohort with the maximum tolerated dose (MTD) determined in Phase I.

Patients will be included in the expansion cohort up to a total of 27, including Phase I patients.

Being tested
CAR-T cells therapy
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • CAR-T cells therapyBiological

    CAR-T cells therapy

Study groups in NCT06378190
Study groupRoleWhat they receive
TranspoCART19 cellsExperimentalAdult differentiated, autologous, peripheral blood T lymphocytes, expanded and genetically modified.
Receives: Biological: CAR-T cells therapy

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Determine the maximum tolerated dose (MTD) and/or recommended dose of TranspoCART19 cells in patients with relapsed or refractory B-cell lymphoma.

    Measured: 1 month

  2. Efficiency

    Determine best response rate achieved (overall and complete).

    Measured: 3 month

Secondary outcomes (7)

  1. Procedure-related mortality (PRM)

    Rate of mortality, defined as any death not directly caused by lymphoma.

    Measured: 1 month - 3 month

  2. Toxicity assessment

    Number of grade II-IV adverse events using Common Toxicity Criteria (CTC) version 5.0

    Measured: 1 month - 3 month - 12 month - 36 month

  3. Response (overall and complete)

    Best response rate achieved (overall and complete) following Lugano classification (PET-CT treatment response)

    Measured: 1 month - 3 month - 12 month - 36 month

  4. Duration of response

    Time (month) in overall response and complete response.

    Measured: 36 month

  5. Progression-free survival (PFS)

    Time (month) between infusion of TranspoCART19 and disease progression or death.

    Measured: 12 month - 24 month

  6. Overall survival (OS)

    Time (month) between infusion of TranspoCART19 and death of the patient from any cause.

    Measured: 12 month - 24 month

  7. Perceived general well-being

    Evaluation of quality of life using EuroQol-5 Dimension-5 levels (EQ-5D-5L) questionnaire [score range from 0 (the worst health status for that dimension) to 100 (the best health status)]

    Measured: 3 month -6 month -12 month

Timeline

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

  1. First posted22 Apr 2024
  2. Study start11 Mar 2024
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2030 (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
Phase I/II, pilot, open, national, prospective, multicentre, non-randomised
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378190
Sponsor's protocol ID
TranspoCART19
Other IDs
2022-001040-23, 2024-514544-90-00
Acronym
TranspoCART19
Status last verified
Apr 2026
First submitted
16 Feb 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Diez B, Calvino C, Fernandez-Garcia M, Rodriguez-Marquez P, Rodriguez-Diaz S, Martinez-Turillas R, Ceballos C, Illarramendi J, Serrano-Lopez J, Miskey C, Navarro-Bailon A, Lopez-Corral L, Llamas P, Redondo M, Sanchez-Guijo F, Rifon J, Alfonso-Pierola A, Ivics Z, Inoges S, Lopez-Diaz de Cerio A, Yanez R, Bueren JA, Rodriguez-Madoz JR, Prosper F. Generation and GMP scale-up of human CAR-T cells using non-viral Sleeping Beauty transposons for B cell malignances. Mol Ther Methods Clin Dev. 2025 Jan 31;33(1):101425. doi: 10.1016/j.omtm.2025.101425. eCollection 2025 Mar 13.

    PubMed 40034423

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T cells therapy in people with Refractory B-Cell Lymphoma and B-cell Lymphoma Recurrent, run by Instituto de Investigación Biomédica de Salamanca at 8 sites 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Esperanza López_Franco, PhD (923 291200 ext. 55779, uicec.coordinacion@ibsal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 1 month). The study lists 2 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 NCT06378190, 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 16 Apr 2026.

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