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 now · Phase 1

Conditions studied: Non-Hodgkin Lymphoma, Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05794958

Run by

Stanford University

People needed

20

Starts

2023-05-23

Expected to finish

2038-04-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:
• 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
• 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.
• 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).
• 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.
• Age 18 years or older
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1. ECOG 2 permitted if performance status is solely attributed to lymphoma.
• 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
• 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.
• 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)
• 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.
• If prior CD19 directed therapy, demonstrates CD19 positivity by biopsy (Flow cytometry or immunohistochemistry per the institutional criteria)
• 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

You may not qualify if…

• Prior treatment with CAR-T or adoptive cell therapy.
• Prior allogeneic transplant.
• No bridging therapy permitted except for steroids or radiotherapy (bridging therapy with steroids e.g. dexamethasone 40 mg for 5 days or radiotherapy is permitted). Measurable non-irradiated lesion post-apheresis needed for enrollment.
• Active central nervous system disease from lymphoma. MRI of the brain with no evidence of CNS lymphoma if prior history of CNS involvement.
• Prior history of allergic reactions or severe infusion reaction to Axi-Cel or any of the reagents used in the Axi-Cel infusion.
• History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
• Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.
• Women who are pregnant or breastfeeding
• History of invasive malignancy unless the patient has been disease-free for five years.
• 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.
• History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication.
• 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.

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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