Clinical trial · Interventional
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Diffuse Large B Cell Lymphoma Refractory | — | UNRESOLVED | — |
| Diffuse Large B Cell Lymphoma Relapsed | — | UNRESOLVED | — |
| Large B-cell Lymphoma | — | UNRESOLVED | — |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin Lymphoma Refractory/ Relapsed | — | UNRESOLVED | — |
| Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axicabtagene ciloleucel | Biological | Axicabtagene Ciloleucel | ALIAS |
| lisocabtagene maraleucel | Biological | Lisocabtagene Maraleucel | ALIAS |
| rondecabtagene autoleucel | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rondecabtagene autoleucel
- interventionNames
- Biological: rondecabtagene autoleucel
- type
- ACTIVE_COMPARATOR
- label
- Investigator's Choice CD19
- description
- axicabtagene ciloleucel, lisocabtagene maraleucel
- interventionNames
- Biological: axicabtagene ciloleucel
- Biological: lisocabtagene maraleucel
Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 36 months
- description
- The time interval from treatment initiation until the occurrence of a specific event of interest.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy 2. 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) 3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy 4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: 1. Patients ineligible to receive CD19 CAR T-cell therapy 2. Primary CNS lymphoma 3. 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 transformation) 4. 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 5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment 6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply
References
Publications (0)
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