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Compares treatment options for Large B-cell Lymphoma
Official title A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
ClinicalTrials.gov ID: NCT07188558
What this study is testing
What is rondecabtagene autoleucel?
rondecabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as LYL314.
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 Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
- Phase 3: a large, late-stage study
- 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
- CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
- Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
- Diffuse large B-cell lymphoma (DLBCL)
- Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
- DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
You likely can't join if
- Patients ineligible to receive CD19 CAR T-cell therapy
- Primary CNS lymphoma
- Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation...
- Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2...
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other...
- Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply
See the full eligibility criteria
- CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
- Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
- Diffuse large B-cell lymphoma (DLBCL)
- Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
- DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
- High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B)
- Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy
- Measurable disease by presence of [18F]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key
- Patients ineligible to receive CD19 CAR T-cell therapy
- Primary CNS lymphoma
- Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's...
- Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years
- Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment
- Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
+ 14 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 - 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?
Study sites include Gilbert, Arizona, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Aurora, Colorado, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.