Lymph node cancer
Conditions
Interventions
Single infusion of 2.5 × 106 CAR transduced autologous T cells per kg/body
weight (BW) (with a maximum dose equivalent to 100 kg for participants with a
body weight > 100 kg). The Investigational me
Sponsors
Miltenyi Biomedicine GmbH
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven DLBCL and associated subtypes, according to the World Health Organisation (WHO) 2016 classification. 2. Relapsed or refractory disease after first line chemoimmunotherapy. 3. Participants must have received adequate first-line therapy containing at least the combination of an anthracycline based regimen and rituximab (anti CD20 monoclonal antibody). Local therapies (e.g. radiotherapies) will not be considered as line of therapy if performed during the same line of treatment. 4. Archival paraffin-embedded tumour tissue acquired = 18 years. 7. 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. Estimated life expectancy of > 3 months for other reasons than the primary disease. 9. Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures. Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures 10. In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations. 11. Mental capacity and legal ability to consent to participation in the clinical study. FOR FULL LIST OF INCLUSION CRITERIA PLEASE REFER TO THE STUDY PROTOCOL
Exclusion criteria
Exclusion criteria: 1. Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician. 2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy. 3. Participants who have received more than one line of treatment for DLBCL or associated subtypes. 4. Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) 2. 6. Absolute neutrophil count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or CR at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on Independent Review Committee (IRC) assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Key Efficacy Endpoints: 1. Progression-free survival (PFS), defined as the time between the date of randomisation and the date of objective disease progression or death of any cause, whichever occurs first, based on IRC assessment. 2. Best complete response rate (BCRR), defined as the proportion of participants with at least one complete response (CR) assessment until Week 24 in the MB-CART2019.1 arm and Week 26 in the comparator arm based on IRC assessment. 3. Duration of complete response (DOCR), defined as the time between the date of a first CR and the date of assessment of objective disease progression or the date of death of any cause, whichever occurs first, based on IRC assessment. 4. Overall survival (OS), defined as time between the date of randomisation and the date of death of any cause. Other Secondary Endpoints: • PFS rates at 6 and at 12 months based on investigator assessment and based on IRC assessment. • PFS based on investigator assessment. • EFS based on investigator assessment. • EFS rates at 6 and at 12 months based on investigator assessment and based on IRC assessment. • Time to new anti-lymphoma therapy defined as the time between the date of randomisation and the date of the event (start of new anti-lymphoma therapy or death of any cause). • BCRR, defined as the proportion of participants with at least one CR assessment until Week 24 in the MB-CART2019.1 arm and Week 26 in the comparator arm based on investigator assessment. • BCRR until Week 48 in the MB-CART2019.1 arm and Week 50 in the comparator arm based on investigator assessment and based on IRC assessment. • Modified BCRR (mBCRR), defined as the proportion of participants with at least one CR assessment without symptoms (B symptoms, symptomatic splenomegaly, symptomatic hepatomegaly, symptomatic lymphadenopathy and infections) at the time of this CR based on investigator assessment and based on IRC assessment. • DOCR, defined as | — |
Countries
Netherlands
Outcome results
None listed