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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

No Placebo-Only Group

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

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My leukemia is CD19 positive.

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I am fully active or can carry out light work.

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My blood cell counts are within a healthy range.

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My cancer is in complete remission with very few cancer cells left after initial treatment.

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My cancer has fully responded to treatment, including in the brain or spinal cord.

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I am 18 years old or older.

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I am a woman who can have children and I have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Lymphopenia

Abdominal pain

Arthralgia

Neuropathy peripheral

Pruritus

Pneumonia

Bradycardia

Gait disturbance

Sinusitis

International normalised ratio increased

Weight increased

Disturbance in attention

Lethargy

Memory impairment

Agitation

Acute kidney injury

Rash maculo-papular

Febrile neutropenia

Dysphagia

Pain

Oropharyngeal pain

Deep vein thrombosis

Oral candidiasis

Atrial fibrillation

Oral pain

Vision blurred

Hyperkalaemia

Hypermagnesaemia

Dysphonia

Respiratory failure

Dry mouth

Malaise

Oedema

Dehydration

Nasal congestion

Sepsis

Embolism

Abdominal distension

Alopecia

Neck pain

Non-cardiac chest pain

Herpes zoster

Influenza

Hypernatraemia

Fall

Depression

B-cell lymphoma

Stomatitis

Generalised oedema

Urinary tract infection

Weight decreased

Dysarthria

Dysgeusia

Irritability

Pulmonary oedema

Wheezing

Orthostatic hypotension

Seizure

Tooth infection

Ventricular arrhythmia

Blood fibrinogen decreased

Staphylococcal bacteraemia

Dysuria

Urinary incontinence

Lung infection

Malnutrition

Myopathy

Atrial flutter

Pancreatic haemorrhage

Autoimmune colitis

Cytomegalovirus infection

Appendicitis

Enterococcal infection

Second primary malignancy

Brain oedema

Pulmonary embolism

Sinus bradycardia

Papilloedema

C-reactive protein increased

Bone pain

Amnesia

Cognitive disorder

Nystagmus

Paraesthesia

Syncope

Dry skin

Face oedema

Stomatitis necrotising

Bronchitis

Soft tissue infection

Ejection fraction decreased

Leukaemia

Organising pneumonia

Acne

Ear pain

Abdominal pain upper

Dyspepsia

Paraesthesia oral

Respiratory syncytial virus infection

Septic shock

Skin infection

Streptococcal bacteraemia

Femur fracture

Transaminases increased

Urine output decreased

Joint effusion

Intensive care unit acquired weakness

Acute respiratory distress syndrome

Distributive shock

Shock haemorrhagic

Gastrooesophageal reflux disease

Troponin increased

Flank pain

Muscle atrophy

Musculoskeletal pain

Pain in extremity

Dyskinesia

Skin ulcer

Pancreatitis

Multiple organ dysfunction syndrome

Arthritis infective

Device related infection

Hydronephrosis

Communication disorder

Mental status changes

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met