Clinical trial for Large B-cell Lymphoma
Official title Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
ClinicalTrials.gov ID: NCT06500273
What this study is testing
What is cemacabtagene ansegedleucel?
This is an investigational cell therapy being studied as a potential treatment for large B-cell lymphoma. It is designed to use modified immune cells to find and target cells that have a specific marker called CD19.
Also referred to as cema-cel.
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
- This study aims to find out if adding a specific cell therapy after standard treatment is safer and more effective than just watching for signs of return.
- Who it's for
- Adults with large B-cell lymphoma who finished first-line treatment and appear to be in remission but still have tiny amounts of cancer cells detected by a special test.
- What's involved
- Participants are randomly assigned to either receive the new cell therapy (cema-cel) after a short course of chemotherapy to lower white blood cells, or to continue with standard monitoring without extra treatment.
- Time commitment
- The study involves initial preparation with chemotherapy followed by the cell therapy infusion or continued observation, with follow-up visits to monitor health and test for cancer cells.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically...
- Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended.
- Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
- Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
- Adult participants ≥18 years of age.
You likely can't join if
- LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone...
- Prior treatment with anti-CD19 targeted therapies.
- Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
- Active and clinically significant autoimmune disease.
- Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
- History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
See the full eligibility criteria
- LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
- Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
- Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
- Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
- Adult participants ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
- Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1. Key
- LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
- Prior treatment with anti-CD19 targeted therapies.
- Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
- Active and clinically significant autoimmune disease.
- Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
- History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- Hot Springs, Arkansas, United States
- Berkeley, California, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Lone Tree, Colorado, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
+ 50 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 Gilbert, Arizona, United States; Hot Springs, Arkansas, United States; Berkeley, California, United States; Duarte, California, United States; Los Angeles, California, United States; Sacramento, California, United States and 64 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.