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Clinical Trial 19072

Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Julio Chavez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

Summary

The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating their disease.

Objective

The primary objective is to estimate the efficacy of axicabtagene ciloleucel, as measured by objective response rate, in subjects with relapsed or refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). A key secondary endpoint will be progression-free survival (PFS). Additional secondary objectives will include additional safety and efficacy endpoints.

Inclusion Criteria

  • Age 18 years or older
  • Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin Lymphoma (iNHL), with histological subtype limited to FL Grade 1, Grade 2, or Grade 3a or Marginal Zone Lymphoma (MZL) nodal or extranodal, based on criteria established by the World Health Organization (WHO) 2016 classification.
  • Relapsed or refractory disease after 2 or more prior lines of therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with an alkylating agent. (Single agent anti-CD20 antibody will not count as line of therapy for eligibility). Stable disease (without relapse) > 1 year from completion of last therapy is not eligible.
  • Have measurable disease. > No known history or suspicion of central nervous system (CNS) involvement by lymphoma.
  • > At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy and enrollment, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy and enrollment.
  • Toxicities due to prior therapy must be stable and recovered ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function.
  • Females not pregnant or breastfeeding
  • Males and females willing to use birth control from the time of consent through 6 months following CAR T cell infusion.

    • Exclusion Criteria

  • Transformed follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL).
  • Small lymphocytic lymphoma.
  • Histological Grade 3b FL
  • Lymphoplasmacytic lymphoma.
  • History of malignancy other than non-melanoma skin cancer or carcinoma in situ, unless disease free and without anticancer therapy for at least 3 years.
  • Will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
  • Prior CD19 targeted therapy, with the exception of subjects who received axicabtagene ciloleucel in this study and are eligible for retreatment.
  • Prior CAR therapy or other genetically modified T-cell therapy.
  • Has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g., mass effect, tumor lysis syndrome, etc.)
  • Other exclusions may apply

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