← Back to Search

CAR T-cell Therapy

CAR-T Therapy for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Led By Bijal D. Shah, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests if CAR-T therapy is safe and effective in treating B-ALL patients in remission with minimal disease.

Who is the study for?
Adults over 18 with B-cell acute lymphoblastic leukemia (B-ALL) that's CD19 positive can join. They must be in remission but still have minimal residual disease after induction chemotherapy. Participants need to be generally healthy, able to follow the trial schedule, and willing to use birth control during and for 6 months after the study.
What is being tested?
The trial is testing KTE-X19 CAR T-cell therapy's effectiveness and safety in treating B-ALL patients who are in remission but have some remaining cancer cells detectable at very low levels.
What are the potential side effects?
KTE-X19 may cause immune system reactions, fever, fatigue, headache, breathing difficulties, changes in blood pressure or heart rate. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia is CD19 positive.
Select...
I am fully active or can carry out light work.
Select...
My blood cell counts are within a healthy range.
Select...
My cancer is in complete remission with very few cancer cells left after initial treatment.
Select...
My cancer has fully responded to treatment, including in the brain or spinal cord.
Select...
I am 18 years old or older.
Select...
I am a woman who can have children and I have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Relapse Free Survival (RFS)
Secondary study objectives
Clinical Relapse Rate
Duration of Response (DOR)
Molecular Relapse Free Survival (MRFS)
+5 more

Side effects data

From 2023 Phase 2 trial • 105 Patients • NCT02601313
91%
CYTOKINE RELEASE SYNDROME
87%
Pyrexia
68%
Anaemia
53%
Platelet count decreased
51%
Neutrophil count decreased
43%
Hypotension
40%
White blood cell count decreased
40%
Chills
37%
Hypophosphataemia
37%
Neutropenia
37%
Cough
35%
Headache
35%
Tremor
35%
Fatigue
34%
Hypoalbuminaemia
34%
Hypoxia
32%
Hyponatraemia
32%
Nausea
31%
Alanine aminotransferase increased
31%
Hypokalaemia
29%
Constipation
28%
Tachycardia
28%
Hypocalcaemia
26%
Diarrhoea
22%
Thrombocytopenia
22%
Oedema peripheral
22%
Encephalopathy
21%
Hyperglycaemia
21%
Aspartate aminotransferase increased
21%
Decreased appetite
19%
Asthenia
19%
Confusional state
19%
Hypertension
19%
Dyspnoea
18%
Insomnia
18%
Pleural effusion
15%
Hypogammaglobulinaemia
15%
Anxiety
15%
Hypomagnesaemia
13%
Sinus tachycardia
13%
Leukopenia
13%
Dizziness
13%
Rash
13%
Upper respiratory tract infection
13%
Muscular weakness
13%
Aphasia
12%
Blood creatinine increased
12%
Back pain
12%
Lymphocyte count decreased
12%
Blood alkaline phosphatase increased
12%
Urinary retention
10%
Vomiting
10%
Somnolence
10%
Blood bilirubin increased
10%
Myalgia
9%
Lymphopenia
9%
Abdominal pain
9%
Arthralgia
9%
Neuropathy peripheral
9%
Pruritus
7%
Pneumonia
7%
Bradycardia
7%
Gait disturbance
7%
Sinusitis
7%
International normalised ratio increased
7%
Weight increased
7%
Disturbance in attention
7%
Lethargy
7%
Memory impairment
7%
Agitation
7%
Acute kidney injury
7%
Rash maculo-papular
7%
Febrile neutropenia
7%
Dysphagia
7%
Pain
7%
Oropharyngeal pain
7%
Deep vein thrombosis
6%
Oral candidiasis
6%
Atrial fibrillation
6%
Oral pain
6%
Vision blurred
6%
Hyperkalaemia
6%
Hypermagnesaemia
6%
Dysphonia
6%
Respiratory failure
6%
Dry mouth
6%
Malaise
6%
Oedema
6%
Dehydration
6%
Nasal congestion
6%
Sepsis
6%
Embolism
4%
Abdominal distension
4%
Alopecia
4%
Neck pain
4%
Non-cardiac chest pain
4%
Herpes zoster
4%
Influenza
4%
Hypernatraemia
4%
Fall
4%
Depression
3%
B-cell lymphoma
3%
Stomatitis
3%
Generalised oedema
3%
Urinary tract infection
3%
Weight decreased
3%
Dysarthria
3%
Dysgeusia
3%
Irritability
3%
Pulmonary oedema
3%
Wheezing
3%
Orthostatic hypotension
3%
Seizure
3%
Tooth infection
3%
Ventricular arrhythmia
3%
Blood fibrinogen decreased
3%
Staphylococcal bacteraemia
3%
Dysuria
3%
Urinary incontinence
3%
Lung infection
1%
Malnutrition
1%
Myopathy
1%
Atrial flutter
1%
Pancreatic haemorrhage
1%
Autoimmune colitis
1%
Cytomegalovirus infection
1%
Appendicitis
1%
Enterococcal infection
1%
Second primary malignancy
1%
Brain oedema
1%
Pulmonary embolism
1%
Sinus bradycardia
1%
Papilloedema
1%
C-reactive protein increased
1%
Bone pain
1%
Amnesia
1%
Cognitive disorder
1%
Nystagmus
1%
Paraesthesia
1%
Syncope
1%
Dry skin
1%
Face oedema
1%
Stomatitis necrotising
1%
Bronchitis
1%
Soft tissue infection
1%
Ejection fraction decreased
1%
Leukaemia
1%
Organising pneumonia
1%
Acne
1%
Ear pain
1%
Abdominal pain upper
1%
Dyspepsia
1%
Paraesthesia oral
1%
Respiratory syncytial virus infection
1%
Septic shock
1%
Skin infection
1%
Streptococcal bacteraemia
1%
Femur fracture
1%
Transaminases increased
1%
Urine output decreased
1%
Joint effusion
1%
Intensive care unit acquired weakness
1%
Acute respiratory distress syndrome
1%
Distributive shock
1%
Shock haemorrhagic
1%
Gastrooesophageal reflux disease
1%
Troponin increased
1%
Flank pain
1%
Muscle atrophy
1%
Musculoskeletal pain
1%
Pain in extremity
1%
Dyskinesia
1%
Skin ulcer
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Arthritis infective
1%
Device related infection
1%
Hydronephrosis
1%
Communication disorder
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
2 x 10^6 Axicabtagene Ciloleucel
Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous CAR T-cell immunotherapyExperimental Treatment1 Intervention
Tecartus will be delivered at a target dose of 1x106 cells / kg. For those \>100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy.

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyIndustry Sponsor
44 Previous Clinical Trials
3,920 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,480 Total Patients Enrolled
Bijal D. Shah, MDPrincipal InvestigatorMoffitt Cancer Center
~40 spots leftby Nov 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top