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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05794958
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
May 23, 2023
Status verified
Sep 2025
Primary completion
Apr 1, 2038
Completion
Apr 1, 2038

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Safety Run-in phase
    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.
  • Experimental: Phase 1b
    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

Primary Outcome Measure

Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL. [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Kelly Chyan, MPH
[email protected]
650-725-8130
Sally Arai, MD (SUB_INVESTIGATOR)
Laura Johnston, MD (SUB_INVESTIGATOR)
Robert Lowsky, MD (SUB_INVESTIGATOR)
Everett Meyer, MD, PhD (SUB_INVESTIGATOR)
Robert Negrin, MD (SUB_INVESTIGATOR)
Andrew Rezvani, MD (SUB_INVESTIGATOR)
Judith Shizuru, MD, PhD (SUB_INVESTIGATOR)
Wen-Kai Weng, MD, PhD (SUB_INVESTIGATOR)
Praveen Shiraz, MD (SUB_INVESTIGATOR)
Matthew Frank, MD, PhD (SUB_INVESTIGATOR)
Surbhi Sidana, MD (SUB_INVESTIGATOR)
Lori Muffly, MD, MS (SUB_INVESTIGATOR)
Melody Smith, MD (SUB_INVESTIGATOR)
David B. Miklos, MD, PhD (SUB_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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