A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
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This study will look at the safety, effectiveness (efficacy) and tolerability of an investigational drug called loncastuximab tesirine in combination with other anti-cancer drugs polatuzumab vedotin, glofitamab and mosunetuzumab for patients with relapsed or refractory B-cell Non- Hodgkin Lymphoma. Loncastuximab tesirine is an antibody drug conjugate (ADC), which is a type of medicine that combines an antibody (a protein that binds to specific substances in the body) with a chemotherapy drug that can kill cells. The antibody part of the study drug potentially helps direct the chemotherapy to cancer cells and kill them. Loncastuximab tesirine is approved by the US FDA for use in patients with a type of B cell NonHodgkins Lymphoma called diffuse large B cell lymphoma, also known as “DLBCL” that has gotten worse (refractory) or come back (relapsed) after two or more study treatment s but is not approved for use in combination with another anti-cancer agent for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. The other anti-cancer agents being investigated in combination with loncastuximab tesirine include the following: - polatuzumab vedotin which is approved for patients with relapsed or refractory DLBCL in US and EU, or - mosunetuzumab (only the formulation of intravenous infusion – directly into a vein) which is approved for patients with Relapsed or Refractory Follicular Lymphoma (R/R FL) or - glofitamab reported durable complete remissions and favorable safety in patients with R/R DLBCL but is not approved yet.
Are you Eligible? (Inclusion Criteria)
- Must be 18 years or older - Must not be breastfeeding or pregnant - Must not have had a vaccine within 4 weeks of start of study treatment - Must not have used the drug loncastuximab tesirine