What side effects are associated with this type of intervention?

CAR-T cell therapies, such as those targeting CD19 in B-cell lymphoma, are associated with several significant side effects. These include cytokine release syndrome (CRS), which can cause fever, hypotension, and respiratory distress, and neurotoxicity, which may present as confusion, seizures, or encephalopathy. Other common adverse effects include cytopenias (low blood cell counts), infections, and fatigue. These therapies can achieve durable remissions but require careful monitoring and management of these potentially life-threatening toxicities.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of B-cell lymphomas, including brexucabtagene autoleucel (KTE-X19), which targets CD19. These therapies have shown high rates of overall response and complete remission in patients with relapsed or refractory B-cell lymphomas. Other similar CAR-T cell therapies include axicabtagene ciloleucel and tisagenlecleucel, which also target CD19 and have been approved for various B-cell malignancies.

What other types of research exist?

Promising novel alternatives to KITE-363 and KITE-753 for B-cell lymphoma patients include: 1) Other CAR-T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel. 2) Bispecific T cell engagers (BiTEs) like teclistamab and AMG 701. 3) Novel targeted agents such as iberdomide (a CELMoD targeting cereblon) and talquetamab (targeting GPRC5D and CD3). These therapies are under active investigation and have shown potential in clinical trials.

← Back to Search

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

Must not have

Known history of HIV infection, HBV HBsAg positive infection, or HCV positive infection

History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and proper dosage of two new drugs, KITE-363 and KITE-753, in patients whose B-cell lymphoma has returned or not responded to other treatments. The goal is to find out if these drugs can effectively target and kill the resistant cancer cells.

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.

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.

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 below

Select...

My B-cell lymphoma has returned or did not respond to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of HIV, hepatitis B, or hepatitis C.

Select...

My leukemia or lymphoma has changed into a more aggressive form.

Select...

I have had a stem cell transplant from a donor.

Select...

I am a woman who has been sterilized or have not had a period for at least 2 years.

Select...

I had a stem cell transplant within the last 6 weeks before my planned treatment.

Select...

I have an infection that needs strong antibiotics or antifungals.

Select...

I have or had cancer cells in my brain or spinal fluid.

Select...

I am not pregnant or breastfeeding.

Select...

I have a history of or currently have a brain or nervous system disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Complete Response (CR) Rate for KITE-363 or KITE-753

Duration of Response (DOR) for KITE-363 or KITE-753

Overall Survival (OS) for KITE-363 or KITE-753

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CAR-T cell therapy, a common treatment for B-Cell Lymphoma, involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that targets specific proteins on B-cell lymphoma cells, such as CD19. This enables the T cells to recognize and destroy the cancerous B cells. This targeted approach is crucial for B-Cell Lymphoma patients as it can lead to durable remissions, particularly in relapsed or refractory cases, and offers a personalized treatment option that may improve patient outcomes.