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CAR T-cell Therapy

KITE-197 for Large B-cell Lymphoma

Phase 1

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or Refractory Large B-cell Lymphoma

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is studying the safety, tolerability and effectiveness of a study drug, KITE-197, for people with relapsed or refractory large B-cell lymphoma. It has 2 phases to evaluate safety & effectiveness, and measure CR rate.

Who is the study for?

This trial is for individuals with relapsed or refractory Large B-cell Lymphoma who have at least one measurable lesion and proper organ and bone marrow function. It's not suitable for those who don't meet these health requirements.Check my eligibility

What is being tested?

The study tests KITE-197, alongside Cyclophosphamide and Fludarabine, in two phases: Phase 1a focuses on safety, tolerability, and dosing; Phase 1b assesses the effectiveness of KITE-197 at the recommended dose by looking at remission rates.See study design

What are the potential side effects?

Potential side effects may include reactions to the infusion of KITE-197, as well as impacts from Cyclophosphamide and Fludarabine such as nausea, hair loss, mouth sores, decreased blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My large B-cell lymphoma has returned or is not responding to treatment.

Select...

It looks like there might be a mistake or missing information in your request. Could you please provide more details or clarify the criterion you'd like to have rewritten in simpler language?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)

Phase 1b: Complete Remission (CR) Rate

Secondary outcome measures

Duration of Response (DOR)

Event Free Survival (EFS)

Number of KITE-197 CAR T Cells in Blood Over Time Post Infusion

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: KITE-197Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

43 Previous Clinical Trials

3,617 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

28 Previous Clinical Trials

2,975 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaging in this research project?

"Affirmative. Clinicaltrials.gov attests that this experiment, initially posted on November 9th 2023 is actively admitting patients. 39 individuals need to be conscripted from 1 research centre."

Answered by AI

Is this research endeavor currently seeking participants?

"As indicated on clinicaltrials.gov, this trial is currently accepting participants. Initially posted on November 9th 2023 and subsequently revised four days later, the experiment seeks to recruit patients for its experiments."

Answered by AI

Is KITE-197 considered to be an innocuous medication for people?

"The safety of KITE-197 has been given a rating of 1, as it is currently in Phase 1 trials. Evidence towards its efficacy and safety is still limited at this stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of KITE-197 in Participants With Relapsed or Refractory Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079164.

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