Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
NCT ID: NCT06378190
Last Updated: 2026-02-06
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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RECRUITING
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2024-03-11
2030-07-31
Brief Summary
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Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TranspoCART19 cells
Adult differentiated, autologous, peripheral blood T lymphocytes, expanded and genetically modified.
CAR-T cells therapy
CAR-T cells therapy
Interventions
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CAR-T cells therapy
CAR-T cells therapy
Eligibility Criteria
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Inclusion Criteria
2. Age over 18 years and under 80 years.
3. 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).
4. Adequate bone marrow haematopoietic reserve.
5. Life expectancy of at least 2 months.
6. Adequate venous access for lymphapheresis. Absence of contraindications for lymphapheresis.
7. Signed informed consent (patient or legal guardian).
Exclusion Criteria
2. 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.
3. 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.
4. 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).
5. Active infection requiring systemic medical treatment.
6. HIV infection.
7. 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.
8. 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.
9. Positive serology for hepatitis C virus (HCV), defined as a positive test for anti-HCV antibodies that is confirmed by Recombinant immunoblot assay (RIBA).
10. 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.
11. Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test at screening.
12. 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.
13. 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.
14. Need to take glucocorticoids chronically in doses greater than 10 mg/day of prednisone (or equivalent) or other chronic immunosuppressants.
15. 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.
16. Hypersensitivity to the active substance or to any of the excipients.
18 Years
80 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
Fundación Canaria de Investigación Sanitaria
OTHER
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
UNKNOWN
Instituto de Investigación Biomédica de Salamanca
OTHER
Responsible Party
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Locations
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Hospital Clínic
Barcelona, Barcelona, Spain
Institut Català d'Oncologia Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Fundación Jiménez Díaz Hospital
Madrid, Madrid, Spain
Virgen de la Arrixaca University Hospital
El Palmar, Mur, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
University Hospital of Navarra
Pamplona, Navarre, Spain
Salamanca University Health Care Complex
Salamanca, SALAMANCA, Spain
Virgen del Rocio Hospital
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Nuria Martínez Cibrian
Role: backup
Alberto Musetti
Role: backup
Javier Cornago-Navascués
Role: backup
Joaquín Gómez-Espuch
Role: backup
Carlos Grande
Role: backup
María Carmen Mateos-Rodríguez
Role: backup
Lucía López-Corral, PhD
Role: backup
José Antonio Pérez-Simón
Role: backup
References
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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.
Other Identifiers
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2022-001040-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-514544-90-00
Identifier Type: CTIS
Identifier Source: secondary_id
TranspoCART19
Identifier Type: -
Identifier Source: org_study_id
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