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Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy | Clinical Trials | Clareo Health

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Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

NCT07479797•Kite, A Gilead Company

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory large B-cell lymphoma (LBCL) after one prior line of therapy. The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\) Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
•Who:
•i. Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:
•1. Progressive disease (PD) and/or Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment or as the end of treatment response following first-line therapy
•2. Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)
•3. PR as best response after at least 6 cycles of first-line therapy (eg, 6 cycles of R-CHOP)
•Note: A biopsy is recommended to confirm residual disease.
•ii. Individuals with relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapsed ≤ 12 months of completion of first-line therapy
•Note: If the relapse is confirmed by imaging per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma {Cheson 2014} within 12 months, the confirmatory biopsy must be performed within 90 days of the 12 month cutoff.
•iii. Prior therapy must have included an anti-CD20 antibody (including CD20-targeting T-cell engager antibodies) and an anthracycline-containing chemotherapy regimen.
+38 more criteria

Exclusion Criteria

•1. Prior CAR T-cell therapy or other cell-based therapy
•2. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without anti-cancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Individuals with asymptomatic localized low-grade prostate cancer for which a watch-and-wait approach is standard of care are eligible.
•3. Individuals with the following LBCL fifth edition of World Health Organization (WHO) criteria subtypes (Alaggio 2022): Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, T-cell/histiocyte-rich LBCL, mediastinal gray zone lymphoma, plasmablastic lymphoma, intravascular LBCL, primary central nervous system (CNS) lymphoma, primary vitreoretinal LBCL, fibrin-associated LBCL, fluid overload-associated LBCL lymphomatoid granulomatosis, high-grade B-cell lymphoma (HGBCL) with 11q aberrations, anaplastic lymphoma kinase-positive LBCL, LBCL with Interferon Regulatory Factor 4 (IRF4) rearrangement, and transformed from HL.
•Note: Individuals with primary testicular LBCL are eligible.
•4. History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
•5. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the individual is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (ie, temperature \< 38°C).
•6. Known history of hepatitis B virus (HBV) (hepatitis B surface (HBs) antigen (HBsAg) positive) infection, or hepatitis C (anti-hepatitis C virus (HCV)) positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing.

Key Dates

Start Date

August 1, 2026

Primary Completion Date

May 1, 2031

Completion Date

May 1, 2031

Last Updated

March 18, 2026

Enrollment

550

ESTIMATED participants

Conditions

Relapsed or Refractory Large B-cell Lymphoma (r/r LBCL)

Interventions

KITE-753

DRUG

Axicabtagene Ciloleucel

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Contacts

Medical Information

CONTACT

844-454-5483(1-844-454-KITE)medinfo@kitepharma.com