Actively Recruiting
Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2026-04-16
27
Participants Needed
8
Research Sites
329 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Biomédica de Salamanca
Lead Sponsor
S
Spanish Clinical Research Network - SCReN
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, Mantle cell lymphoma, Follicular lymphoma grades 1-3a, or Marginal lymphoma including splenic, nodal and MALT)
- Age over 18 years and under 80 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; patients with ECOG 2 may be included if due to hematological disease
- Adequate bone marrow hematopoietic reserve
- Life expectancy of at least 2 months
- Adequate venous access for lymphapheresis and no contraindications for the procedure
- Signed informed consent from patient or legal guardian
You will not qualify if you...
- Patients who may benefit from other approved potentially curative treatments including commercial CAR-T therapies
- Treatment with any experimental or non-commercialized substance in the 4 weeks prior to recruitment or participation in another therapeutic clinical trial
- Diagnosis of another neoplasm either past or present, except those in complete remission for over 3 years or certain skin cancers
- Early relapse after allogeneic hematopoietic stem cell transplantation or active immunosuppressive treatment for graft-versus-host disease
- Active infection requiring systemic medical treatment
- HIV infection
- Uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, or psychiatric conditions
- Positive hepatitis B or C serology with specific conditions
- Severe organ involvement as defined by specific clinical measures
- Pregnant or lactating women; women of childbearing age must have negative pregnancy test at screening and agree to use contraception
- Men who are unable or unwilling to use highly effective contraception
- Chronic use of glucocorticoids above 10 mg/day prednisone equivalent or other chronic immunosuppressants
- Previous anti-CD19 CAR-T therapy
- Hypersensitivity to the active substance or any excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hospital Clínic
Barcelona, Barcelona, Spain
Not Yet Recruiting
2
Institut Català d'Oncologia Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Actively Recruiting
3
Fundación Jiménez Díaz Hospital
Madrid, Madrid, Spain
Actively Recruiting
4
Virgen de la Arrixaca University Hospital
El Palmar, Mur, Spain
Actively Recruiting
5
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
6
University Hospital of Navarra
Pamplona, Navarre, Spain
Actively Recruiting
7
Salamanca University Health Care Complex
Salamanca, SALAMANCA, Spain, 37007
Actively Recruiting
8
Virgen del Rocio Hospital
Seville, Sevilla, Spain
Actively Recruiting
Research Team
E
Esperanza López_Franco, PhD
CONTACT
F
Fátima Macho Sánchez-Simón
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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