Health TrialsbyHealthPanel

Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMiltenyi Biomedicine GmbH

About this trial

In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DLBCL not otherwise specified (NOS).

High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements with DLBCL/blastoid/intermediate histology or HGBL with MYC and BCL2 and/or BCL6 rearrangements (double hit lymphoma/triple hit lymphoma).

High-grade BCL, NOS.

Primary (thymic) large mediastinal BCL.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • MB-CART2019.1

    Genetic

    MB-CART2019.1 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies. MB-CART2019.1 consists of autologous cluster of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis and processed by using the CliniMACS Prodigy® device.

  • Standard of Care

    Drug

    Standard of Care

Treatment groups

213 Participants
are divided into 3 treatment groups
Group A: Part I: CAR T-cell MB-CART2019.1Experimental treatment 1 intervention
Group B: Part II: CAR T-cell MB-CART2019.1Experimental treatment 1 intervention
Group C: PART I: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part I: Event-free survival

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 complete response (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.

Time frame
up to 30 weeks after randomisation
2

Part II: Best objective response rate

Best objective response rate (BORR), defined as the proportion of participants with at least one CR or PR between the date of MB-CART2019.1 infusion and the date of objective disease progression, the start of new anti-lymphoma therapy or the date of death from any cause, whichever occurs first, based on IRC assessment.

Time frame
up to 30 weeks after administration of MB-CART2019.1

Secondary outcomes

1

Part I: 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.

Time frame
up to 99 weeks after randomisation
2

Part I: Best complete response rate

To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

Time frame
up to 99 weeks after randomisation
3

Part I: Duration of complete response

To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

Time frame
up to 91 weeks
4

Part I: Overall Survival

To evaluate the safety and toxicity of MB-CART2019.1 compared to SoC therapy.

Time frame
up to 99 weeks after randomisation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Miltenyi Biomedicine GmbH

Lead sponsor

ICON plc

Collaborator

Source ClinicalTrials.gov
Apply now