Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study will have two phases: Phase 1a and Phase 1b.
In Phase 1a (Dose Escalation), participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197.
In Phase 1b (Dose Expansion), additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.
Participants will be followed for approximately 24 months after the infusion of KITE-197 before transitioning to a separate Kite long-term follow-up study (KT-US-982-5968) in which they will be followed for the remainder of the 15-year follow-up period.
Conditions
This trial is treating people with relapsed or refractory large B-cell lymphoma
Eligibility
Inclusion
- Relapsed or Refractory Large B-cell Lymphoma
- At least 1 measurable lesion
- Adequate organ and bone marrow function
Exclusion
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 2 years
- History of Richter's transformation of chronic leukemic lymphoma
- History of allogenic stem cell transplant (SCT)
- Autologous SCT within 6 weeks of planned KITE-197 infusion
- Prior CD19 targeted antibody, such as tafasitamab and loncastuximab with the exception of individuals who have previously achieved an objective response to such therapy and their tumor expresses CD19 by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) at the time of screening. Individuals who meet these criteria may be eligible
- Prior treatment with bendamustine within 6 months of enrollment
- Prior CAR therapy or other genetically modified cell therapy
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management
- History of HIV infection or acute or chronic active hepatitis B or C infection
- History or presence of a clinically significant central nervous system (CNS) disorder Note: Prior or active CNS involvement by lymphoma is not an exclusion criterion.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months before enrollment
- Presence of primary immunodeficiency
- History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
- History of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 3 months before enrollment. Catheter induced DVT which has been treated for at least 6 weeks prior to enrollment is permitted
- Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Kite, A Gilead Company
Scientific Title
A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma
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