RecruitingPhase 2

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

Austria, Belgium213 participantsStarted 2021-08-18

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.
✕. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
✕. Participants who have received more than one line of treatment for DLBCL or associated subtypes.
✕. Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) \< 3 months at the time of leukapheresis.
✕. ECOG performance status \> 2.
✕. 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.

What they're measuring

Part I: Event-free survival

Timeframe: up to 30 weeks after randomisation

Part II: Best objective response rate

Timeframe: up to 30 weeks after administration of MB-CART2019.1

Trial details

NCT IDNCT04844866

SponsorMiltenyi Biomedicine GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

Contact for this trial

Mark Hess, Dr.

+49 160 9897 0124 mark.hess@miltenyi.com

View on ClinicalTrials.gov More Diffuse Large B-cell Lymphoma trials