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Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

ConditionRelapsed and/or Refractory B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKite, A Gilead Company

About this trial

The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Relapsed and/or refractory B-cell lymphoma (R/R BCL).

At least 1 measurable lesion.

Adequate organ and bone marrow (BM) function.

Disqualifiers

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.

History of allogeneic stem cell transplant (allo-SCT).

Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.

Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy administered intravenously

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy administered intravenously

  • KITE-363

    Biological/Vaccine

    A single infusion of CAR-transduced autologous T cells administered intravenously

  • KITE-753

    Biological/Vaccine

    A single infusion of CAR-transduced autologous T cells administered intravenously

Treatment groups

247 Participants
are divided into 3 treatment groups
Group A: Phase 1 a/b: KITE-363Experimental treatment 3 interventions
Group B: Phase 1 a/b: KITE-753Experimental treatment 3 interventions
Group C: Phase 2: KITE-753Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 or KITE-753

DLTs are defined as the KITE-363-related or KITE-753-related events with onset within the first 28 days after the infusion of KITE-363 or KITE-753 respectively.

Time frame
Up to 28 days
2

Phase 1b: Objective Response Rate (ORR) for KITE-363 and KITE-753 as per investigator's assessment.

ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) by the International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

Time frame
Up to 15 years
3

Phase 2: ORR as per central assessment for KITE-753

Time frame
Up to 15 years

Secondary outcomes

1

Phase 1a/b: Percentage of Participants Experiencing Adverse Events (AEs) After the Infusion of KITE-363 and KITE-753

Time frame
Up to 15 years
2

Phase 1a/b: Percentage of Participants Experiencing Serious AEs (SAEs) After the Infusion of KITE-363 and KITE-753

Time frame
Up to 15 years
3

Phase 1a/b: Time To Next Treatment (TTNT) for KITE-363 and KITE-753

TTNT is defined as the time from KITE-363 or KITE-753 infusion to the next anticancer treatment (including stem cell transplantation \[SCT\]) or death from any cause, whichever occurs first.

Time frame
Up to 15 years
4

Phase 1a/b: Complete Response (CR) Rate for KITE-363 and KITE-753

CR rate is defined as the incidence of a CR by the IWG Lugano Response Criteria for Malignant Lymphoma (Cheson 2014) as determined by investigator assessment.

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kite, A Gilead Company

Lead sponsor

Source ClinicalTrials.gov
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