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

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Kite, A Gilead Company

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

No Placebo Group

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.

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

+11 more

Trial 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

Participant Groups

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.

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.