Phase 2
Completed N=27
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
Source: ClinicalTrials.gov NCT04002401 ↗Enrolled (actual)
27
Serious AEs
53.8%
Results posted
Feb 2024
Primary outcomePrimary: Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators — 73 percentage of participants
Summary
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators |
73 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) |
100 | — |
| SECONDARY Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value |
12; 12; 8; 8; 15; 19 | — |
| SECONDARY Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators |
88 | — |
| SECONDARY Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators |
26.0 | — |
| SECONDARY Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators |
23.6 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Peak Level of Anti-CD19 CAR T Cells in Blood |
40.33 | — |
| SECONDARY Level of Anti-CD19 CAR T Cells in Blood by Visit |
0.00; 18.11; 12.74; 4.66; 1.66; 0.99 | — |
| SECONDARY Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28) |
376.83 | — |
| SECONDARY Time to Peak Level of Anti-CD19 CAR T Cells in Blood |
8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Histologically confirmed large B-cell lymphoma
- Chemotherapy-refractory disease, defined as one or more of the following:
- No response to first-line therapy (primary refractory disease)
- No response to second or greater lines of therapy OR
- Refractory after autologous stem cell transplant (ASCT)
- At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
- Individuals must have received adequate prior therapy, including at a minimum:
- Anti-CD20 monoclonal antibody
- An anthracycline-containing chemotherapy regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate renal, hepatic, pulmonary, and cardiac function
Key Exclusion Criteria
- Known CD19 negative or CD20 negative tumor
- History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
- Prior CAR therapy or other genetically modified T-cell therapy
- Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
- Prior CD19 targeted therapy
- Clinically significant infection or cardiopulmonary disease
- Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed)
- History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases
- History of autoimmune disease
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 6 months
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04002401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.