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NCT05794958 | RECRUITING | Non-Hodgkin Lymphoma

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
Sponsor:

Stanford University

Brief Summary:

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.

Condition or disease

Non-Hodgkin Lymphoma

Large B-cell Lymphoma

Intervention/treatment

Axicabtagene Ciloleucel

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase Ib, Open Label Study to 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
Actual Study Start Date : 2023-05-23
Estimated Primary Completion Date : 2038-04-01
Estimated Study Completion Date : 2038-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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
    • 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 Criteria
      • 1. Prior treatment with CAR-T or adoptive cell therapy.
      • 2. Prior allogeneic transplant.
      • 3. 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.
      • 4. Active central nervous system disease from lymphoma. MRI of the brain with no evidence of CNS lymphoma if prior history of CNS involvement.
      • 5. Prior history of allergic reactions or severe infusion reaction to Axi-Cel or any of the reagents used in the Axi-Cel infusion.
      • 6. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
      • 7. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.
      • 8. Women who are pregnant or breastfeeding
      • 9. 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.
      • 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.
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

Location Details

NCT05794958

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Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94305