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

NCT05794958 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: IRB-68723CCT5068NCI-2023-05593
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin Lymphoma; Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL.

  Subjects will be assessment for dose limiting toxicity (DLT) for 28 days after the infusion of Axi-Cel-2

  28 days

Secondary Outcomes (1)

• Progression free survival (PFS)

  12 months

Study Arms (2)

Safety Run-in phase

ACTIVE COMPARATOR

First three patients (maximum of 6) will receive 0.5 x 106/kg CART cells (25% standard dose) as reinfusion product between days 7 through 14 if CRS/ICANS has resolved to a grade 1 or less.

Drug: Axicabtagene Ciloleucel

Phase 1b

EXPERIMENTAL

Up to 20 evaluable subjects will receive the target dose of AxiCel infusion to evaluate efficacy of Axi-Cel-2 in adults with high risk relapsed/refractory LBCL

Drug: Axicabtagene Ciloleucel

Interventions

Axicabtagene Ciloleucel DRUG

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 ≤ grade 1.

Also known as: (Axi-cel-2)

Phase 1b; Safety Run-in phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Stanford University: lead
• Kite Pharma: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

axicabtagene ciloleucel

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Saurabh Dahiya, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Chyan, MPH

CONTACT

(650) 725-8130; kchyan@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): April 1, 2038
• Study Completion (Estimated): April 1, 2038
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)