KITE-363/KITE-753 for B-cell Lymphoma

Recruiting at 14 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kite, A Gilead Company

Disqualifiers: Other malignancies, CNS disorders, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

114 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Eligibility Criteria

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.

Inclusion Criteria

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

At least 1 measurable lesion

My organs and bone marrow are functioning well.

Exclusion Criteria

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

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

Primary immunodeficiency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1a (Dose Escalation)

Participants receive lymphodepleting chemotherapy followed by a single target starting dose of KITE-363 or KITE-753. Additional participants are enrolled based on dose limiting toxicities observed.

4 weeks

Treatment Phase 1b (Dose Expansion)

After dose escalation, additional participants receive lymphodepleting chemotherapy followed by a single dose of KITE-363 or KITE-753 at a tolerable dose level.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, transitioning to a long-term follow-up study for 15 years.

15 years

Treatment Details

Interventions

• Cyclophosphamide
• Fludarabine
• KITE-363

Trial Overview 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.

Participant Groups

Group I: KITE-753 Experimental Treatment 3 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-363 Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials

45

Recruited

4,300+