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CAR T-cell Therapy
Axicabtagene Ciloleucel for Non-Hodgkin Lymphoma
Palo Alto, CA
Phase 1
Recruiting
Led By Saurabh Dahiya, MD
Research Sponsored by Stanford University
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 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug to see if it's safe to use to treat people with a type of lymphoma that is hard to treat.
See full description
Who is the study for?
Adults over 18 with high-risk Large B Cell Lymphoma who've had one prior treatment can join. They must have normal organ function, not be pregnant or breastfeeding, agree to use birth control, and cannot have a history of certain cancers or severe reactions to Axi-Cel. Those with central nervous system lymphoma, previous CAR-T therapy, or conditions affecting study participation are excluded.
What is being tested?
The trial is testing the safety of a second infusion of Axicabtagene Ciloleucel (Axi-Cel-2) in patients whose aggressive Non-Hodgkin's Lymphoma has returned after initial treatment. It aims to see if reinfusing can help without causing significant harm.See study design
What are the potential side effects?
Potential side effects include immune system reactions that may affect organs, symptoms related to infusion such as fever and chills, blood abnormalities, fatigue, breathing difficulties and possibly others based on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL.
Side effects data
From 2024 Phase 3 trial • 359 Patients • NCT0339146688%
Pyrexia
44%
Neutropenia
42%
Diarrhoea
42%
Anaemia
41%
Headache
41%
Fatigue
40%
Nausea
39%
Hypotension
34%
Sinus tachycardia
30%
Neutrophil count decreased
27%
Chills
27%
White blood cell count decreased
26%
Hypophosphataemia
26%
Hypokalaemia
25%
Decreased appetite
25%
Cough
24%
Tremor
21%
Dizziness
20%
Constipation
20%
Confusional state
20%
Hypoxia
19%
Vomiting
18%
Aphasia
18%
Lymphocyte count decreased
18%
Alanine aminotransferase increased
18%
Platelet count decreased
16%
Hypocalcaemia
16%
Hyperglycaemia
14%
Aspartate aminotransferase increased
14%
Abdominal pain
13%
Hypoalbuminaemia
13%
Thrombocytopenia
12%
Hypomagnesaemia
12%
Oedema peripheral
12%
Insomnia
11%
Encephalopathy
11%
Hypogammaglobulinaemia
11%
Hyponatraemia
11%
Arthralgia
10%
Muscular weakness
9%
C-reactive protein increased
9%
Dry mouth
9%
Serum ferritin increased
9%
Back pain
9%
Malaise
9%
Hypertension
8%
Oral candidiasis
8%
Pain in extremity
8%
Asthenia
8%
Somnolence
8%
Myalgia
8%
Tachycardia
7%
Acute kidney injury
7%
Dyspnoea
7%
Urinary incontinence
6%
Blood creatinine increased
6%
Weight decreased
6%
Erythema
6%
Hypertransaminasaemia
6%
Anxiety
6%
Pneumonia
6%
Oropharyngeal pain
6%
Pleural effusion
6%
Blood alkaline phosphatase increased
5%
Leukopenia
5%
Upper respiratory tract infection
4%
Bone pain
4%
Pruritus
4%
Paraesthesia
4%
B-cell lymphoma
4%
Covid-19
4%
Febrile neutropenia
3%
Dyspepsia
3%
Atrial fibrillation
3%
Hiccups
2%
Stomatitis
2%
Dysgeusia
2%
Alopecia
2%
Sepsis
2%
Abdominal distension
1%
Hepatitis B reactivation
1%
Food poisoning
1%
Fall
1%
Ataxia
1%
Infusion related reaction
1%
Ventricular tachycardia
1%
Rhinovirus infection
1%
Anal squamous cell carcinoma
1%
Agitation
1%
Bradyphrenia
1%
Orthostatic hypotension
1%
Gastrointestinal infection
1%
Vision blurred
1%
Fungal cystitis
1%
Haematopoietic stem cell mobilisation
1%
Pneumonia staphylococcal
1%
Lung opacity
1%
Pseudomonal sepsis
1%
Cardiac arrest
1%
Urinary tract infection
1%
Seizure
1%
Mental status changes
1%
Depressed level of consciousness
1%
Dermatitis
1%
Cardiac failure
1%
Dysarthria
1%
Facial paralysis
1%
Lethargy
1%
Delirium
1%
Respiratory failure
1%
Syncope
1%
Cytomegalovirus infection
1%
Covid-19 pneumonia
1%
Oral disorder
1%
Embolism
1%
Sinusitis
1%
Pneumocystis jirovecii pneumonia
1%
Enterovesical fistula
1%
Weight increased
1%
Myelodysplastic syndrome
1%
Spindle cell sarcoma
1%
Dyspraxia
1%
Memory impairment
1%
Cholangitis
1%
Plasma cell myeloma
1%
Tachypnoea
1%
Metapneumovirus infection
1%
Pyelonephritis
1%
Salmonella bacteraemia
1%
Progressive multifocal leukoencephalopathy
1%
Urosepsis
1%
Hypoaesthesia
1%
Hemiparesis
1%
Myocardial infarction
1%
Adenocarcinoma of colon
1%
Lung adenocarcinoma
1%
Cardiomyopathy
1%
Pericardial effusion
1%
Wound infection
1%
Femoral neck fracture
1%
Subdural haematoma
1%
Troponin I increased
1%
Hepatocellular carcinoma
1%
Chronic obstructive pulmonary disease
1%
Mucosal inflammation
1%
Flank pain
1%
Acute respiratory failure
1%
Oesophageal fistula
1%
Incarcerated hernia
1%
Influenza
1%
Respiratory tract infection
1%
Blood fibrinogen decreased
1%
Acute myeloid leukaemia
1%
Cerebrovascular accident
1%
Pelvic abscess
1%
Cognitive disorder
1%
Faecaluria
1%
Coagulopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel
Standard of Care Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1bExperimental Treatment1 Intervention
Up to 20 evaluable subjects will receive the target dose of AxiCel infusion to evaluate efficacy of Axi-Cel-2 in adults with high risk relapsed/refractory LBCL
Group II: Safety Run-in phaseActive Control1 Intervention
First three patients (maximum of 6) will receive 0.5 x 106/kg CART cells (25% standard dose) as reinfusion product between days 7 through 14 if CRS/ICANS has resolved to a grade 1 or less.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2020
Completed Phase 3
~870
Find a Location
Closest Location:Stanford University· Palo Alto, CA
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,522 Previous Clinical Trials
17,427,690 Total Patients Enrolled
Kite PharmaUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Saurabh Dahiya, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma has spread to my brain or spinal cord.I am fully active or restricted in physically strenuous activity but can do light work.My lymphoma is high-risk with elevated LDH levels.I have previously undergone CAR-T or adoptive cell therapy.I have had a transplant from a donor.I have had a stroke or seizure within the last year.My biopsy shows CD19 positivity after previous CD19 therapy.My organs and bone marrow are functioning normally.My kidney, liver, lung, and heart functions are all within normal ranges.I have had at least one treatment for large B-cell lymphoma.I am 18 years old or older.I haven't had any cancer besides this one in the last 5 years.I am of childbearing age and my pregnancy test is negative.I have been diagnosed with a specific type of aggressive B cell NHL.My lymphoma has transformed into a more aggressive form.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-in phase
- Group 2: Phase 1b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.