Actively Recruiting
Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel
Led by Stanford University · Updated on 2025-09-23
20
Participants Needed
1
Research Sites
775 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
K
Kite Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase Ib study to establish safety of Axi-Cel-2 in patients with Large B Cell Lymphoma (LBCL) who are at high risk of relapse.
CONDITIONS
Official Title
Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed aggressive B cell non-Hodgkin lymphoma including diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, transformed follicular or marginal zone lymphoma, or high grade B-cell lymphoma NOS
- High-risk lymphoma defined by LDH above institutional upper limit of normal at or within two weeks of leukapheresis
- Received exactly one prior line of therapy for large B-cell lymphoma
- At least one measurable lesion on PET-CT or CT scan; lymph nodes 1.5 cm if only lymph node disease
- Age 18 years or older
- ECOG performance status 0 or 1; ECOG 2 allowed if due to lymphoma alone
- Normal organ and marrow function including ANC 1,000/uL, platelet count 75,000/uL, creatinine clearance 60 mL/min, liver enzymes 2.5 x ULN (unless liver lymphoma involvement), bilirubin 1.5 mg/dl (except Gilbert's syndrome), cardiac ejection fraction 40%, no significant pleural effusion or ascites, oxygen saturation > 92% on room air
- Ability to understand and sign informed consent
- Negative pregnancy test for females of childbearing potential
- Willingness to use contraception during study and 12 months after lymphodepletion
- If prior CD19 therapy, lymphoma must be CD19 positive
- At least 2 weeks or 5 half-lives washout since any prior systemic therapy before leukapheresis
You will not qualify if you...
- Prior treatment with CAR-T or adoptive cell therapy
- Prior allogeneic transplant
- Bridging therapy not allowed except steroids or radiotherapy; measurable non-irradiated lesion required after apheresis
- Active central nervous system lymphoma; MRI brain without CNS lymphoma if history of CNS involvement
- History of severe allergic or infusion reactions to Axi-Cel or its reagents
- History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma
- Any medical condition interfering with safety or efficacy assessment
- Pregnant or breastfeeding women
- History of invasive malignancy unless disease-free for 5 years except certain skin and in situ cancers
- History of stroke, transient ischemic attack, or seizure disorder requiring active medication within 12 months
- Unlikely to complete study visits or comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
K
Kelly Chyan, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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