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Monoclonal Antibodies

KTE-C19 for B-Cell Lymphoma (ZUMA-6 Trial)

Phase 1 & 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first kte-c19 infusion to the date of death regardless of cause (maximum duration: 6.2 years)
Awards & highlights

ZUMA-6 Trial Summary

This study is evaluating whether a combination of a drug and a light therapy can be safe and effective for people with lymphoma.

Eligible Conditions
  • B-Cell Lymphoma

ZUMA-6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first kte-c19 infusion to the date of death regardless of cause (maximum duration: 6.2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first kte-c19 infusion to the date of death regardless of cause (maximum duration: 6.2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 and 2: Complete Response Rate (CRR)
Phase 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Phase 1 and 2: Atezolizumab Levels in Blood
Phase 1 and 2: Duration of Response (DOR)
Phase 1 and 2: Objective Response Rate (ORR)
+14 more

Side effects data

From 2023 Phase 1 & 2 trial • 37 Patients • NCT02926833
100%
Encephalopathy
100%
Pyrexia
100%
Cytokine release syndrome
100%
Hypotension
67%
Hypokalaemia
67%
Hypoxia
67%
Anaemia
67%
Neutropenia
67%
Fatigue
67%
Constipation
67%
Abdominal pain
67%
Hypoalbuminaemia
67%
Hypophosphataemia
33%
Post lumbar puncture syndrome
33%
Lung infection
33%
Dyspnoea
33%
Sinus tachycardia
33%
Blood bilirubin increased
33%
Malignant melanoma
33%
Oral disorder
33%
Leukopenia
33%
Platelet count decreased
33%
Syncope
33%
Asthenia
33%
Confusional state
33%
Dizziness
33%
Neutrophil count decreased
33%
Chills
33%
Hypersensitivity
33%
Headache
33%
Dry mouth
33%
Pneumonia
33%
Oral candidiasis
33%
Hypocalcaemia
33%
Malnutrition
33%
Benign prostatic hyperplasia
33%
Ear pruritus
33%
Anal incontinence
33%
Flatulence
33%
Nausea
33%
Candida infection
33%
Dacryocystitis
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Lymphocyte count decreased
33%
Weight decreased
33%
White blood cell count decreased
33%
Decreased appetite
33%
Dehydration
33%
Hyperglycaemia
33%
Hypomagnesaemia
33%
Hyponatraemia
33%
Neck pain
33%
B-cell lymphoma
33%
Aphasia
33%
Cognitive disorder
33%
Tremor
33%
Anxiety
33%
Dysuria
33%
Urinary incontinence
33%
Cough
33%
Rash
33%
Dyspepsia
33%
Immunoglobulins decreased
33%
Fall
33%
Thrombocytopenia
33%
Atrial fibrillation
33%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Cohort 1: KTE-C19 + ATZ (21 Days After KTE-C19)
Phase 1 Cohort 2: KTE-C19 + ATZ (14 Days After KTE-C19)
Phase 1 Cohort 3: KTE-C19 + ATZ (1 Day After KTE-C19)
Phase 2: KTE-C19 + ATZ (1 Day After KTE-C19)

ZUMA-6 Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: KTE-C19 + ATZ (After 1 Day of KTE-C19)Experimental Treatment4 Interventions
Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Group II: Phase 1 Cohort 3: KTE-C19 + ATZ (After 1 Day of KTE-C19)Experimental Treatment4 Interventions
Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19.
Group III: Phase 1 Cohort 2: KTE-C19 + ATZ (After 14 Days of KTE-C19)Experimental Treatment4 Interventions
Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19.
Group IV: Phase 1 Cohort 1: KTE-C19 + ATZ (After 21 Days of KTE-C19)Experimental Treatment4 Interventions
Participants received conditioning chemotherapy consisting of 30 mg/m^2 fludarabine and 500 mg/m^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KTE-C19
2016
Completed Phase 2
~40
Atezolizumab
2017
Completed Phase 3
~5860
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,619 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,106 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,977 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
2016. "Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02926833.
~4 spots leftby Apr 2025
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