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Phase I/IIa multicentre study of infusion of autologous peripheral blood T lymphocytes expanded and genetically modified using Sleeping Beauty family transposons to express a chimeric antigenic receptor with anti-CD19 specificity conjugated to the 4-1BB co-stimulatory region and CD3z and huEGFRt signal transmission (TranspoCART19) in patients with relapsed or refractory B-cell lymphoma.
EU CTIS ID: 2024-514544-90-00
What this study is testing
Phase I: To determine the recommended optimal dose (RP2D) of TranspoCART19 cells and to evaluate the safety of their administration in patients with relapsed or refractory B-cell lymphoma. Pase II: To evaluate the efficacy of TranspoCART19 cell infusion in patients with relapsed or refractory B-cell lymphoma.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with relapsed or refractory B-cell lymphoma who meet the following conditions: • Diffuse large B-cell lymphoma with relapsed or refractory disease after at least 2 lines of systemic therapy and non-candidate or relapsed after autologous haematopoietic stem cell transplantation. Includes follicular lymphoma grade 3b and lymphomas transformed from any indolent entity, primary mediastinal lymphoma and high-grade B lymphoma (double/triple Hit and high-grade lymphoma NOS). • Primary diffuse diffuse large B-cell CNS lymphoma refractory or relapsed after 1 or more lines of systemic therapy including a high-dose methotrexate regimen. • Refractory mantle cell lymphoma with disease or relapsed after at least one line of treatment (including an anthracycline or bendamustine based regimen, anti-CD20 monoclonal antibody and BTKi treatment: ibrutinib, acalabrutinib...). • Follicular lymphoma (grades 1, 2 or 3a) histologically confirmed in the 6 months prior to screening (and after the last line of treatment received), refractory or relapsed, who have received at least 2 systemic treatment regimens (one of them including an antiCD20 such as rituximab, obinutuzumab). Post-transplant relapsed patients and patients with follicular lymphoma after one line of if they are POD24 or meet GELF criteria for treatment (see Annex II) may be included. • Marginal lymphoma, including splenic, nodal and MALT, histologically confirmed within 6 months prior to screening (and after the last line of treatment), refractory or relapsed, having received at least 2 systemic treatment regimens (one of them including an antiCD20 rituximab, obinutuzumab and an alkylating agent, or relapsed after autologous transplantation.
- Age over 18 years and under 80 years.
- Functional status ECOG 0-1. Patients with ECOG 2 may be included if motivated by haematological disease (Protocol Annex III).
- Adequate bone marrow haematopoietic reserve.
- Life expectancy of at least 2 months.
- Adequate venous access for lymphapheresis. Absence of contraindications for the procedure.
You likely can't join if
- Patients who may benefit from other approved therapeutic options.
- Severe organ impairment, defined as cardiac ejection fraction <40%; 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.
- Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase.
- 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 contraception from the start of the study until the end of the study.
- 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 chronic glucocorticoids in doses higher than 10 mg/day of prednisone (or equivalent) or other chronic immunosuppressants.
See the full eligibility criteria
Who can join
- Patients diagnosed with relapsed or refractory B-cell lymphoma who meet the following conditions: • Diffuse large B-cell lymphoma with relapsed or refractory disease after at least 2 lines of systemic therapy and non-candidate or relapsed after autologous haematopoietic stem cell transplantation. Includes follicular lymphoma grade 3b and lymphomas transformed from any indolent entity, primary mediastinal lymphoma and high-grade B lymphoma (double/triple Hit and high-grade lymphoma NOS). • Primary diffuse diffuse large B-cell CNS lymphoma refractory or relapsed after 1 or more lines of systemic therapy including a high-dose methotrexate regimen. • Refractory mantle cell lymphoma with disease or relapsed after at least one line of treatment (including an anthracycline or bendamustine based regimen, anti-CD20 monoclonal antibody and BTKi treatment: ibrutinib, acalabrutinib...). • Follicular lymphoma (grades 1, 2 or 3a) histologically confirmed in the 6 months prior to screening (and after the last line of treatment received), refractory or relapsed, who have received at least 2 systemic treatment regimens (one of them including an antiCD20 such as rituximab, obinutuzumab). Post-transplant relapsed patients and patients with follicular lymphoma after one line of if they are POD24 or meet GELF criteria for treatment (see Annex II) may be included. • Marginal lymphoma, including splenic, nodal and MALT, histologically confirmed within 6 months prior to screening (and after the last line of treatment), refractory or relapsed, having received at least 2 systemic treatment regimens (one of them including an antiCD20 rituximab, obinutuzumab and an alkylating agent, or relapsed after autologous transplantation.
- Age over 18 years and under 80 years.
- Functional status ECOG 0-1. Patients with ECOG 2 may be included if motivated by haematological disease (Protocol Annex III).
- Adequate bone marrow haematopoietic reserve.
- Life expectancy of at least 2 months.
- Adequate venous access for lymphapheresis. Absence of contraindications for the procedure.
- Signature of informed consent (patient or legal guardian).
What rules you out
- Patients who may benefit from other approved therapeutic options.
- Severe organ impairment, defined as cardiac ejection fraction <40%; 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.
- Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase.
- 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 contraception from the start of the study until the end of the study.
- 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 chronic glucocorticoids in doses higher than 10 mg/day of prednisone (or equivalent) or other chronic immunosuppressants.
- Previously received CAR-T antiCD19 therapy. Previous treatment with other antiCD19 strategies is allowed, provided that CD19 expression has been confirmed in the tumour biopsy.
- Treatment with any experimental or non-marketed substance in the four weeks prior to recruitment, or actively participating in another therapeutic clinical trial.
- Diagnosis of another neoplasm, past or present. Patients 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 graft-versus-host disease (corticosteroids or other systemic immunosuppressants).
- 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 patient.
- Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies, a hepatitis B virus DNA test will be required, and if the result is positive, the patient will be excluded.
- Positive serology for hepatitis C, defined as a positive test for anti-HCV antibodies that is confirmed by RIBA.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.