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Compares treatment options for Relapsed or Refractory Large B-cell Lymphoma
Official title Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
ClinicalTrials.gov ID: NCT07479797
What this study is testing
What is KITE-753?
KITE-753 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 (r/r) 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
- World Health Organization (WHO):
- Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:
- Progressive disease (PD) and/or Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment...
- Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and...
You likely can't join if
- Prior CAR T-cell therapy or other cell-based therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without...
- Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic...
- History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for...
- Known history of hepatitis B virus (HBV) (hepatitis B surface (HBs) antigen (HBsAg) positive) infection, or hepatitis C (anti-hepatitis C virus...
See the full eligibility criteria
Who can join
- Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
- World Health Organization (WHO):
- Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:
- 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.
- Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)).
- 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.
- 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 within 12 months, the confirmatory biopsy must be performed within 90 days of the...
- Prior therapy must have included an anti-CD20 antibody (including CD20-targeting T-cell engager antibodies) and an anthracycline-containing chemotherapy regimen.
- For individuals with transformed indolent NHL, therapies given for non-transformed disease do not count as a line of therapy for the transformed disease.
- Individuals who have had no additional systemic therapy or holding therapy (except for steroids and/or local radiation) following first-line therapy and prior to leukapheresis are eligible.
- At least 1 measurable lesion according to the IWG Lugano Response Criteria. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of...
- The following washout period must be satisfied:
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the individual is assigned by chance.
- Toxicities due to immediate prior therapy must have recovered to Grade 1 or lower (except for clinically nonsignificant toxicities such as alopecia, unless otherwise specified in the protocol)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate bone marrow function as evidenced by:
- Absolute neutrophil count ≥ 1,000/μL or ≥ 500/μL if documented bone marrow involvement of lymphoma. Bone marrow involvement by lymphoma is demonstrated by positron emission tomography (PET) scan or bone marrow...
- Platelet count ≥ 75,000/μL (unless secondary to bone marrow or spleen involvement by lymphoma, in which platelet count ≥ 50,000 μL is permitted). Bone marrow involvement by lymphoma is demonstrated by PET scan or bone...
- Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
- Creatine clearance (as estimated by Cockcroft-Gault formula) ≥ 30 mL/minute. Note: 24-hour urine estimate is also acceptable.
- Serum alanine aminotransferase/aspartate aminotransferase ≤ 3.0 times the upper limits of normal, except in individuals with documented liver involvement by lymphoma via PET-diagnostic CT scan or biopsy
- Total bilirubin ≤ 1.5 mg/dL, except in individuals with Gilbert's Syndrome or documented liver or pancreatic involvement where ≤ 3.0 times the upper limit of normal is permitted
- Cardiac ejection fraction ≥ 40% and no pericardial effusion Grade 3 or higher (per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0) as determined by an echocardiogram (ECHO) or multiple-gated...
- No evidence of Grade 2 (per CTCAE v5.0) or greater pleural effusion or ascites (individuals with Grade 1 ascites or pleural effusion are eligible)
- Baseline oxygen saturation \> 92% on room air
- Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test (females who have undergone surgical sterilization or have been postmenopausal for at least 2 years before...
What rules you out
- Prior CAR T-cell therapy or other cell-based therapy.
- 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...
- Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma...
- History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management. Note: Simple urinary tract infections and uncomplicated bacterial or...
- 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...
- HIV-positive, unless taking appropriate anti-HIV medications, with an undetectable viral load by qPCR and a CD4 count ≥ 200 cells/μL. Note: HIV-positive individuals in Australia are not permitted regardless of active...
- History or presence of the following CNS disorders: hemorrhage, dementia (per CTCAE v5.0 Grade 2 or higher memory impairment), cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible...
- History of stroke or transient ischemic attack within 6 months before enrollment. Individuals with seizure disorders requiring active anticonvulsive medication.
- Individuals with cardiac atrial or cardiac ventricular lymphoma involvement.
- Individuals with secondary CNS lymphoma.
- Individuals with full thickness lymphoma involvement of gastric or intestinal lining. Individuals with concern for gastric or intestinal perforation or known contained perforation.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active unstable/uncontrolled arrhythmia, New York Heart Association Class II or greater congestive heart failure, or other clinically...
- Requirement for urgent therapy within 4 weeks before enrollment due to ongoing or impending oncologic emergency (eg, tumor mass effect)
- Presence of primary immunodeficiency.
- History of any medical condition including but not limited to autoimmune disease (eg, Crohn's, rheumatoid arthritis, or systemic lupus) resulting in end organ injury or requiring systemic immunosuppression and/or...
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome.
- Any medical condition or residual toxicities from prior therapies per investigator assessment likely to interfere with the assessments of safety or how well it works of the study treatment.
- History of a severe immediate hypersensitivity reaction or contraindication to any of the agents used in the study (including fludarabine and cyclophosphamide).
- Live vaccine ≤ 6 weeks before randomization, during the treatment period, and until immune recovery following the study treatments (refer to Section 12.10 for additional country-specific requirements, as applicable).
- Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization...
- Individuals of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after the completion of KITE-753 or axi-cel infusion.
- In the investigator's judgment, the individual is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation. Note: Other protocol...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Stanford, California, United States
- Denver, Colorado, United States
- Newnan, Georgia, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- East Melbourne, Victoria, Australia
- Montreal, Canada
- Québec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Stanford, California, United States; Denver, Colorado, United States; Newnan, Georgia, United States; Nashville, Tennessee, United States; Austin, Texas, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.