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New treatment option for Refractory B-Cell Lymphoma
Official title Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology
ClinicalTrials.gov ID: NCT06378190
What this study is testing
What is CAR-T cells therapy?
CAR-T cells therapy is an investigational medicine, being studied as a potential treatment for refractory b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients diagnosed with relapsed or refractory B-cell lymphoma (Diffuse large B-cell lymphoma, Primary diffuse large B-cell lymphoma of the Central...
- 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...
- Adequate bone marrow haematopoietic reserve.
- Life expectancy of at least 2 months.
You likely can't join 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...
- 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...
- Early relapse after allogeneic haematopoietic stem cell transplantation (less than 3 months for lymphapheresis, less than 6 months for TranspoCART19...
- Active infection requiring systemic medical treatment.
- HIV infection.
See the full eligibility criteria
- 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...
- 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).
- 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.
- 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...
- 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...
- 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...
- 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 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Madrid, Madrid, Spain
- El Palmar, Mur, Spain
- Pamplona, Navarre, Spain
- Salamanca, SALAMANCA, Spain
- Seville, Sevilla, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Madrid, Madrid, Spain; El Palmar, Mur, Spain; Pamplona, Navarre, Spain; Salamanca, SALAMANCA, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.