Trial Title:
Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
NCT ID:
NCT06378190
Condition:
Refractory B-Cell Lymphoma
B-cell Lymphoma Recurrent
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Phase I/II, pilot, open, national, prospective, multicentre, non-randomised
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR-T cells therapy
Description:
CAR-T cells therapy
Arm group label:
TranspoCART19 cells
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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).
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:
1. Patients who, in the opinion of a physician, may benefit from other approved
potentially curative therapeutic options, including commercial CAR-Ts.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Català d'Oncologia Hospital
Address:
City:
Hospitalet de Llobregat
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Alberto Musetti
Facility:
Name:
Virgen de la Arrixaca University Hospital
Address:
City:
El Palmar
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Joaquín Gómez-Espuch
Facility:
Name:
Clínica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Carlos Grande
Facility:
Name:
University Hospital of Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
María Carmen Mateos-Rodríguez
Facility:
Name:
Hospital Clínic
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Valentín Ortiz-Maldonado
Facility:
Name:
Fundación Jiménez Díaz Hospital
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Javier Cornago-Navascués
Facility:
Name:
Salamanca University Health Care Complex
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
Lucía López-Corral, PhD
Facility:
Name:
Virgen del Rocio Hospital
Address:
City:
Sevilla
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Esperanza López-Franco, PhD
Phone:
923291200
Phone ext:
55779
Email:
uicec.coordinacion@ibsal.es
Contact backup:
Last name:
José Antonio Pérez-Simón
Start date:
March 11, 2024
Completion date:
October 2028
Lead sponsor:
Agency:
Instituto de Investigación Biomédica de Salamanca
Agency class:
Other
Collaborator:
Agency:
Spanish Clinical Research Network - SCReN
Agency class:
Other
Collaborator:
Agency:
Fundación Canaria de Investigación Sanitaria
Agency class:
Other
Collaborator:
Agency:
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Agency class:
Other
Source:
Instituto de Investigación Biomédica de Salamanca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378190
