Clinical programs
Our oncology research focuses on tandem (dual-antigen) targeting strategies designed to address antigen escape in B-cell malignancies. Manufacturing relies on standardized, automated, closed processes that support GMP-compliant workflows. Beyond hematology, we are expanding our pipeline to explore additional indications, including solid tumors and autoimmune diseases, employing different cell therapy platforms.
Our pipeline
Miltenyi has a diverse portfolio of proprietary product candidates for hematologic cancers, with several clinical trials currently underway or planned for the near future. The graphic shows examples of product candidates in late pre-clinical and clinical development stages. Additionally we are actively expanding our pipeline by applying our platforms to degenerative disorders, and solid tumors such as pancreatic cancer, ovarian cancer and glioblastoma.
Zamtocabtagene
Target: Tandem CD20-CD19
Indication
NCT04844866
A pivotal phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of zamtocabtagene autoleucel 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.
Please visit ClinicalTrials.gov (NCT04844866).
Indication
NCT04792489
A prospective, single arm, open label, multi-center, phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy.
Please visit ClinicalTrials.gov (NTC04792489).
Indication
NCT06508931
A single-arm, multi-center, open-label phase II study designed to evaluate the efficacy of zamtocabtagene autoleucel therapy infusion in pediatric subjects with relapsed/refractory (r/r) mature B-cell neoplasms.
Please visit ClinicalTrials.gov (NCT06508931).
Indication
NCT07288879
A phase II, multi-center, single arm study to evaluate the safety and efficacy of zamtocabtagene autoleucel in subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL)
Please visit rctportal.mhlw.go.jp (JRCT2033250384).
Indication
NCT06708845
A phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.
Please visit ClinicalTrials.gov (NCT06708845).
Zorpocabtagene
Target: CD19
Indication
NCT06347718
A prospective, open-label, non-randomized, single-dose interventional basket study to assess the safety of anti-CD19 CAR-T cell therapy (zorpocabtagene autoleucel) in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM).
Please visit ClinicalTrials.gov (NCT06347718).
Indication
NCT06189157
A phase l/ll open-label, multicentre, interventional single-arm trial of zorpocabtagene autoleucel in patients with refractory SLE systemic lupus erythematosus.
Please visit ClinicalTrials.gov (NCT06189157).
Indication
Indication
NCT03853616
A phase l/ll multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients.
Please visit ClinicalTrials.gov (NCT03853616).
MB-dNPM1-TCR.1
Target: dNPM1
Indication
NCT06424340
A phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A*02:01 in patients with relapsed or refractory AML.
Please visit ClinicalTrials.gov (NCT06424340).
Preclinical
Indication
1 Zamtocabtagene autoleucel and zorpocabtagene autoleucel are proposed International Nonproprietary Names (INN). The safety and efficacy of investigational agents have not been established. Programs details are subject to change.
*Part I complete; Part II recruiting