Lymphoma, Non-Hodgkin study: MK-1045
Official title A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
ClinicalTrials.gov ID: NCT07519772
What this study is testing
What is MK-1045?
an investigational biological immunotherapy being studied as a potential treatment for follicular lymphoma and diffuse large B‑cell lymphoma (types of non‑Hodgkin lymphoma).
Also referred to as CN-201.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe and tolerable MK-1045 is and whether it can make the cancer shrink or disappear.
- Who it's for
- Adults who have been diagnosed with follicular lymphoma or diffuse large B‑cell lymphoma.
- What's involved
- Participants receive MK-1045 infusions and undergo regular lab tests and imaging scans to monitor safety and tumor response.
- Time commitment
- The trial runs for several months and requires multiple clinic visits for treatment infusions and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2...
- Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
- DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
- Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
- Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on...
You likely can't join if
- Has received a solid organ transplant.
- Had or has clinically relevant central nervous system (CNS) diseases.
- Has a history of serious cardiovascular or cerebrovascular diseases.
- Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD)
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received a live or live-attenuated vaccine within 30 days of randomization.
See the full eligibility criteria
- Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
- Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
- DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
- Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
- Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior...
- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
- Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
- Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
- Has radiographically measurable disease per Lugano Response Criteria.
- Has received a solid organ transplant.
- Had or has clinically relevant central nervous system (CNS) diseases.
- Has a history of serious cardiovascular or cerebrovascular diseases.
- Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received a live or live-attenuated vaccine within 30 days of randomization.
- Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
- Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
- Has known active CNS lymphoma or involvement.
- Has active autoimmune disease that required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has a history of severe bleeding disorders.
- Has not recovered from major surgery or has ongoing surgical complications.
- Has diagnosis of primary mediastinal B-cell lymphoma.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Denver, Colorado, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Pilar, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- CABA, Argentina
- Townsville, Queensland, Australia
- Adelaide, South Australia, Australia
- Box Hill, Victoria, Australia
- Curitiba, Paraná, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Santiago, Region M. de Santiago, Chile
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Denver, Colorado, United States; Cleveland, Ohio, United States; Nashville, Tennessee, United States; Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina; Pilar, Buenos Aires, Argentina and 42 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.