NCT06378190

Brief 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 for 36 months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
51mo left

Started Mar 2024

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Mar 2024Jul 2030

First Submitted

Initial submission to the registry

February 16, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

February 16, 2024

Last Update Submit

April 13, 2026

Conditions

Refractory B-Cell LymphomaB-cell Lymphoma Recurrent

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month

  • Efficiency

    Determine best response rate achieved (overall and complete).

    3 month

Secondary Outcomes (7)

  • Procedure-related mortality (PRM)

    1 month - 3 month

  • Toxicity assessment

    1 month - 3 month - 12 month - 36 month

  • Response (overall and complete)

    1 month - 3 month - 12 month - 36 month

  • Duration of response

    36 month

  • Progression-free survival (PFS)

    12 month - 24 month

  • +2 more secondary outcomes

Other Outcomes (7)

  • Molecular and cell biology exploratory objectives: Response dynamics

    days +28, +100, +180; 9 months - 12 months - 18 months - 24 months - 30 months - 36 month. Biopsy: days 7, 14, 28, 56, 100 and 180 - 6 months - 9 months - 12 months -18 months - 24 months - 36 month.

  • Molecular and cell biology exploratory objectives: Response dynamics

    days +28, +100, +180; 9 months - 12 months - 18 months - 24 months - 30 months - 36 month. Biopsy: days 7, 14, 28, 56, 100 and 180 - 6 months - 9 months - 12 months -18 months - 24 months - 36 month.

  • Molecular and cell biology exploratory objectives: Response dynamics

    days +28, +100, +180; 9 months - 12 months - 18 months - 24 months - 30 months - 36 month. Biopsy: days 7, 14, 28, 56, 100 and 180 - 6 months - 9 months - 12 months -18 months - 24 months - 36 month.

  • +4 more other outcomes

Study Arms (1)

TranspoCART19 cells

EXPERIMENTAL

Adult differentiated, autologous, peripheral blood T lymphocytes, expanded and genetically modified.

Biological: CAR-T cells therapy

Interventions

CAR-T cells therapyBIOLOGICAL

CAR-T cells therapy

TranspoCART19 cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Clínic

Barcelona, Barcelona, Spain

NOT YET RECRUITING

Institut Català d'Oncologia Hospital

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Fundación Jiménez Díaz Hospital

Madrid, Madrid, Spain

RECRUITING

Virgen de la Arrixaca University Hospital

El Palmar, Mur, Spain

RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

University Hospital of Navarra

Pamplona, Navarre, Spain

RECRUITING

Salamanca University Health Care Complex

Salamanca, SALAMANCA, 37007, Spain

RECRUITING

Virgen del Rocio Hospital

Seville, Sevilla, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40034423DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Esperanza López_Franco, PhD

CONTACT

923 291200uicec.coordinacion@ibsal.es

Fátima Macho Sánchez-Simón

CONTACT

923 291200uicec.admon@ibsal.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase I/II, pilot, open, national, prospective, multicentre, non-randomised
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2024

First Posted

April 22, 2024

Study Start

March 11, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

ES(8)