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CAR T-cell Therapy
KITE-363/KITE-753 for 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 and/or refractory B-cell lymphoma (R/R BCL)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study Summary
This trial is studying KITE-363 to see how safe and effective it is in treating patients with relapsed or refractory B-cell lymphoma.
Who is the study for?
This trial is for people with B-cell lymphoma that has come back or hasn't responded to treatment. They must have at least one measurable lesion, good organ and bone marrow function, and no major health issues like heart disease or active infections. People with HIV, hepatitis B/C, recent serious blood clots, CNS disorders, or a history of certain other cancers aren't eligible.Check my eligibility
What is being tested?
The study is testing the safety and proper dosing of two drugs: KITE-363 and KITE-753 in participants with relapsed/refractory B-cell lymphoma. It includes preparatory chemotherapy (Cyclophosphamide and Fludarabine) before administering the study drugs.See study design
What are the potential side effects?
Potential side effects may include reactions from the immune system's activation such as fever or fatigue; complications from chemotherapy like nausea; increased risk of infection; possible damage to organs due to inflammation caused by the study drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My B-cell lymphoma has returned or did not respond to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
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 Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753
Phase 1b: Objective Response Rate (ORR) for KITE-363 or KITE-753
Secondary outcome measures
Complete Response (CR) Rate for KITE-363 or KITE-753
Duration of Response (DOR) for KITE-363 or KITE-753
Levels of KITE-363 or KITE-753 CAR T Cells and Analytes (Including Cytokines) in the Blood
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: KITE-753Experimental 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-753 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-753.
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-753 at 1 or more dose-level deemed to be tolerable.
Group II: KITE-363Experimental 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-363 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-363.
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-363 at 1 or more dose-level deemed to be tolerable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,542 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,900 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of HIV, hepatitis B, or hepatitis C.My leukemia or lymphoma has changed into a more aggressive form.My B-cell lymphoma has returned or did not respond to treatment.I have had a stem cell transplant from a donor.I am a woman who has been sterilized or have not had a period for at least 2 years.I haven't had serious heart issues in the last 6 months.I had a stem cell transplant within the last 6 weeks before my planned treatment.I have an infection that needs strong antibiotics or antifungals.I have or had cancer cells in my brain or spinal fluid.I have been cancer-free for 3 years, except for nonmelanoma skin cancer or carcinoma in situ.I am not pregnant or breastfeeding.I have an autoimmune disease and have been on systemic treatment in the past 2 years.I have a history of or currently have a brain or nervous system disorder.I have had a serious blood clot that needed blood thinners in the last 6 months.My organs and bone marrow are functioning well.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: KITE-753
- Group 2: KITE-363
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has KITE-363 been the subject of any other experiments in a controlled environment?
"Currently, 889 active studies are taking place in regards to KITE-363 with 161 of these trials being Phase 3. While the majority of research is centred around Philadelphia, Pennsylvania there exists a total of 28446 locations conducting clinical trials regarding this drug."
Answered by AI
In what instances is KITE-363 typically prescribed?
"KITE-363 is employed to treat multiple sclerosis and a selection of other diseases, such as mixed-cell type lymphoma, acute myelocytic leukemia, and retinoblastoma."
Answered by AI
How many participants can the clinical trial accommodate?
"Kite, A Gilead Company, must recruit 80 individuals who fulfil the eligibility criteria to commence this trial. It will be conducted at various sites such as The University of Texas and MD Anderson Cancer Center in Baltimore (Maryland) plus University of MD, Greenebaum Comprehensive Cancer Center in Stanford (California)."
Answered by AI
Is KITE-363 likely to produce adverse reactions in users?
"As this is an early phase trial, there has only been a limited amount of data collected on KITE-363's safety and efficacy. As such, our team at Power assigned it a score of 1 in terms of security."
Answered by AI
Is there still an opportunity to join this research endeavor?
"As of now, this clinical trial is recruiting new participants. The initial posting date was October 27th 2021 and the study has been kept up-to-date as recently as November 22nd 2022."
Answered by AI
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