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Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma

PHASE1RECRUITING

This study will have two Phases: Phase 1a and Phase 1b. The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or refractory large B-cell lymphoma (r/rLBCL). The goal of Phase 1b of this clinical study is learn about the effectiveness of the recommended dose of KITE-197 in participants with r/r LBCL.

The primary objectives of this study are: Phase 1a: To evaluate the safety of KITE-197 in participants with r/r LBCL and determine the target dose level for Phase 1b. Phase 1b: To evaluate the efficacy of KITE-197 in participants with r/r LBCL as measured by the complete remission (CR) rate.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Relapsed or Refractory Large B-cell Lymphoma

At least 1 measurable lesion

Adequate organ and bone marrow function

Exclusion criteria

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-11-09

Primary completion: 2028-01-01

Study completion finish: 2028-01-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06079164

Intervention or treatment

DRUG: KITE-197

DRUG: Cyclophosphamide

DRUG: Fludarabine

Conditions

• Relapsed/Refractory Large B-cell Lymphoma

$Image related to Relapsed/Refractory Large B-cell Lymphoma$

Condition: Relapsed/Refractory Large B-cell Lymphoma
DRUG: KITE-197 and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Kite, A Gilead Company

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Find a site

Closest Location:

Royal Prince Alfred Hospital

Research sites nearby

Select from list below to view details:

Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
South Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: KITE-197 Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting 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. Phase 1b (Dose Expansion): After completion of dose escalation, 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.	DRUG: KITE-197 A single infusion of CAR-transduced autologous T cells administered intravenously

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: KITE-197

Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting 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.
Phase 1b (Dose Expansion): After completion of dose escalation, 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.

DRUG: KITE-197

A single infusion of CAR-transduced autologous T cells administered intravenously

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)	Not Specified	First infusion date of KITE-197 up to 28 days
Phase 1b: Complete Remission (CR) Rate	Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.	Up to 24 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Percentage of Participants Experiencing Adverse Events (AEs)	Not Specified	Enrollment up to 24 months plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)	Not Specified	Enrollment up to 24 months plus 30 days
Overall Response Rate (ORR)	ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma therapy, per the Lugano Classification, as determined by the investigator.	Up to 24 months
Duration of Response (DOR)	DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.	Up to 24 months
Progression-Free Survival (PFS)	PFS is defined as the time from KITE-197 infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.	Up to 24 months
Event Free Survival (EFS)	EFS is defined as the time from KITE-197 infusion to the earliest occurrence of death due to any cause, disease progression/relapse per investigator, or initiation of new anti-lymphoma therapy.	Up to 24 months
Time to Next Treatment (TTNT)	TTNT is defined as time from KITE-197 infusion to the start of subsequent new lymphoma therapy or death from any cause.	Up to 24 months
Overall Survival (OS)	OS is defined as the time from KITE-197 infusion to death from any cause.	Up to 24 months
Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion	Not Specified	Up to 24 months
Proportion of Immune Cell Subsets in KITE-197	Not Specified	Up to 24 months

Frequently Asked Questions

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References

Clinical Trials Gov: Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma