Generation and GMP scale-up of human CAR-T cells using non-viral Sleeping Beauty transposons for B cell malignances.
Begoña Diez, Cristina Calviño, María Fernández-García...
https://pubmed.ncbi.nlm.nih.gov/40034423Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
ID06378190
Phase I/IIa Study of TranspoCART19 CAR-T Cell Therapy for Relapsed or Refractory B-cell Lymphoma Using Sleeping Beauty Transposon Technology
Led by Instituto de Investigación Biomédica de Salamanca · Updated on 2026-04-16
27
Participants Needed
8
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of a new treatment called TranspoCART19 for patients with relapsed or refractory B-cell lymphoma, a type of blood cancer. This Phase I/II trial aims to find the maximum tolerated dose and response rates of this therapy in patients whose prognosis is less than two years. The study is open-label and conducted at multiple centers in a national setting. The treatment involves autologous peripheral blood T lymphocytes that are expanded and genetically modified using a technology called Sleeping Beauty family transposons to express a chimeric antigen receptor targeting CD19. In Phase I, three dose levels of TranspoCART19 cells will be tested to determine the safest dose, followed by Phase II, where patients will receive the maximum tolerated dose determined earlier. Up to 27 patients will be included in the expansion phase, including those from Phase I. Participants will be followed for 36 months after treatment to assess various outcomes. Assessments include measuring maximum tolerated dose at 1 month, treatment efficiency at 3 months, and ongoing monitoring of toxicity, response rates, survival outcomes, and general well-being at multiple time points up to 36 months. The study involves regular clinical evaluations to track safety and effectiveness of the investigational therapy over time.
CONDITIONS
Brief 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
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory B-cell lymphoma including specific subtypes like diffuse large B-cell lymphoma and mantle cell lymphoma
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; ECOG 2 allowed if justified by hematological disease
- Adequate bone marrow function
- Life expectancy of at least 2 months
- Adequate venous access for lymphapheresis without contraindications
- Signed informed consent by patient or legal guardian
You will not qualify if you...
- Eligible for other approved curative therapies including commercial CAR-T treatments
- Received experimental treatments or participated in another therapeutic clinical trial within 4 weeks prior to recruitment
- Diagnosis of another active or recent neoplasm, except certain skin cancers or completely resected carcinoma in situ
- Early relapse after allogeneic stem cell transplant or current immunosuppressive treatment for graft-versus-host disease
- Active infections requiring systemic treatment
- HIV infection
- Uncontrolled medical illnesses posing risk to patient
- Positive hepatitis B or C serology with active infection
- Severe organ dysfunction as defined by specific clinical measures
- Pregnant or breastfeeding women; women of childbearing potential not using effective contraception
- Men not using highly effective contraception
- Chronic use of high-dose glucocorticoids or immunosuppressants
- Previous anti-CD19 CAR-T therapy
- Hypersensitivity to the investigational product or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 month
Participants receive TranspoCART19 CAR-T cell therapy, an autologous cellular treatment, with dose escalation in Phase I and treatment at the maximum tolerated dose in Phase II.
1 baseline visit and multiple visits during treatment period
Follow-up
Duration - Up to 36 months
Participants are monitored for safety, treatment response, and survival outcomes after treatment with assessments up to 36 months.
Visits at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
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
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Research Team
E
Esperanza López_Franco, PhD
F
Fátima Macho Sánchez-Simón
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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