Safety Study of Axicabtagene Ciloleucel Reinfusion for High-Risk Non-Hodgkin Lymphoma
This study is looking at the safety of giving a second dose of a treatment called axicabtagene ciloleucel (Axi-Cel-2) to people with certain types of non-Hodgkin lymphoma (a cancer of the immune system) that has come back or not responded to previous treatment. Specifically, it's for those with large B-cell lymphoma who are at high risk of their cancer returning. You might be able to join if you are an adult with this type of lymphoma. The main goal is to see how many side effects, especially serious ones, happen within 28 days after receiving this second dose. The study aims to enroll 20 participants, but its current status is unclear.
- Study design
- This is a Phase Ib study, meaning it's an early-stage trial focused on safety. It is an interventional study, and plans to enroll 20 participants.
- What's involved
- Subjects will receive a re-infusion of Axi-Cel (Axi-Cel-2) if signs and symptoms of cytokine release syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) are mild or absent.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoints will be measured at 28 days after the re-infusion.
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NCT05794958
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentStanford UniversityInvestigator-initiated
~20 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:Axicabtagene Ciloleucel
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL.
Measured over 28 days
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Saurabh Dahiya, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diffuse large B cell lymphoma (DLBCL); OR
primary mediastinal (thymic) large B cell lymphoma; OR
transformation of follicular lymphoma (TFL), marginal zone lymphoma to DLBCL; OR
high grade B-cell Lymphoma NOS will also be included 2. Patients must be considered high-risk lymphoma (defined as LDH greater than upper limit of normal per institutional cut-off) at or within two weeks of leukapheresis. 3. Subjects must have received at least and a maximum one prior line of therapy for LBCL indication (i.e subjects receiving second line standard of care Axi-Cel will be enrolled in this study). 4. At least 1 measurable lesion on PET-CT or CT scan. If the only measurable disease is lymph-node disease, at least 1 lymph node should be ≥ 1.5 cm. 5. Age 18 years or older 6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1. ECOG 2 permitted if performance status is solely attributed to lymphoma. 7. Normal Organ and Marrow Function
ANC ≥ 1,000/uL
Platelet count ≥ 75,000/uL
Adequate renal, hepatic, pulmonary and cardiac function defined as:
Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
Serum ALT or AST ≤ 2.5 x ULN (except in subjects with liver involvement by lymphoma)
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.
No clinically significant pleural effusion or ascites
Baseline oxygen saturation \> 92% on room air 8. Ability to understand and the willingness to sign the written IRB-approved informed consent document. Subjects unable to give informed consent will not be eligible for this study. 9. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) 10. Contraception: Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for twelve (12) months after receiving the preparative lymphodepletion regimen. 11. If prior CD19 directed therapy, demonstrates CD19 positivity by biopsy (Flow cytometry or immunohistochemistry per the institutional criteria) 12. Prior therapy washout of at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis
Exclusion
Exception: Nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, and breast) is eligible.
Hormonal therapy in subjects in remission \>1 year will be allowed. 10. History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication. 11. In the investigator's judgment, the subject is unlikely to complete all study specific visits or procedures, including follow-up visits, or comply with the study requirements for participation.
What this trial measures
- Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL.28 days
Subjects will be assessment for dose limiting toxicity (DLT) for 28 days after the infusion of Axi-Cel-2