BridgeMD
DALY 2-EU
EU CTIS ID: 2023-506270-13-00
What this study is testing
Part I: The primary objective is to determine superiority of MB-CART2019.1 treatment compared to standard of care (SoC) therapy with R-GemOx (rituximab, gemcitabine and oxaliplatin) with respect to event-free survival in second-line therapy in participants with R-R DLBCL, who are non-eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT). Part II: The primary objective is to evaluate the efficacy of MB-CART2019.1 in younger, fit participants with R-R DLBCL.
- Therapeutic exploratory (Phase II)
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
- 1. Part I: Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification
- 7. Part I: Measurable disease according to Lugano criteria. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan
- 8. Part I: Estimated life expectancy of > 3 months for other reasons than the primary disease
- 9. Part I: Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures
- 1. Part II: Histologically proven DLBCL and associated subtypes, according to the WHO 2016 classification.
- 2. Part II: Relapsed or refractory disease after first-line chemoimmunotherapy.
You likely can't join if
- 1. Part I: Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.
- 2. Part I: Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
- 3. Part I: Participants who have received more than one line of treatment for DLBCL or associated subtypes.
- 4. Part I: Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) < 3 months at the time of leukapheresis.
- 5. Part I: ECOG performance status (PS) > 2
- 1. Part II: Contraindications for cyclophosphamide and fludarabine as judged by the treating physician.
See the full eligibility criteria
Who can join
- 1. Part I: Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification
- 7. Part I: Measurable disease according to Lugano criteria. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan
- 8. Part I: Estimated life expectancy of > 3 months for other reasons than the primary disease
- 9. Part I: Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures
- 1. Part II: Histologically proven DLBCL and associated subtypes, according to the WHO 2016 classification.
- 2. Part II: Relapsed or refractory disease after first-line chemoimmunotherapy.
- 3. Part II: Participant must have received adequate first-line therapy containing at least the combination of an anthracycline based regimen and rituximab (anti CD20 monoclonal antibody).
- 4. Part II: Archival paraffin embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study.
- 5. Part II: Measurable disease according to Lugano criteria. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan.
- 6. Part II: Approved treatment options not suitable according to investigator’s assessment.
- 7. Part II: Age ≥ 18 and ≤ 70 years.
- 10. Part I: Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures
- 8. Part II: Estimated life expectancy of > 3 months for other reasons than the primary disease.
- 9. Part II: ECOG 0-1.
- 10. Part II: Adequate bone marrow function, defined as: • Absolute neutrophil count ≥ 1,000/µL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy). Platelet count ≥ 50,000/µL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy). • Absolute lymphocyte count ≥ 100/µL.
- 11. Part II: Adequate organ function, defined as: • New York Heart Association class < 2 or LVEF ≥ 50%. • No severe cardiac arrhythmias or QT prolongation (resting QTcF < 450 msec [male] or < 460 msec [female] at screening). • No clinically relevant pleural effusion or pericardial effusion. • Resting peripheral oxygen saturation ≥ 92% on room air. • Total bilirubin ≤ 2.0 × ULN, AST and/or ALT ≤ 5 × ULN. • Serum creatinine < 1.0 × ULN or eGFR (according to modified MDRD formula) ≥ 60 mL/min.
- 12. Part II: WOCBP must agree to use highly effective contraceptive measures
- 13. Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures.
- 14. Part II: In the opinion of the investigator, the participant must be able to comply with all study related procedures, medication use and evaluations.
- 15. Part II: Mental capacity and legal ability to consent to participation in the clinical study.
- 11. Part I: In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations
- 12. Part I: Mental capacity and legal ability to consent to participation in the clinical study.
- 2. Part I: Relapsed or refractory disease after first-line chemoimmunotherapy
- 3. Part I: Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody).
- 4. Part I: Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan.
- 5. Part I: Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician’s assessment
- 6. Part I: Age ≥ 18 years
What rules you out
- 1. Part I: Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.
- 2. Part I: Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
- 3. Part I: Participants who have received more than one line of treatment for DLBCL or associated subtypes.
- 4. Part I: Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) < 3 months at the time of leukapheresis.
- 5. Part I: ECOG performance status (PS) > 2
- 1. Part II: Contraindications for cyclophosphamide and fludarabine as judged by the treating physician.
- 2. Part II: Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
- 3. Part II: Participants who have received more than one line of prior therapy for DLBCL or associated subtypes.
- 4. Part II: Prior HSCT (as first-line consolidation) < 3 months at the time of leukapheresis.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey. 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 EU CTIS; the study team decides eligibility.