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CAR T-cell Therapy
Axicabtagene Ciloleucel for Non-Hodgkin Lymphoma
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.
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.
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 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Diarrhoea
31%
Tachycardia
31%
Hypokalaemia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
Dizziness
23%
B-cell lymphoma
23%
Tremor
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Hyponatraemia
19%
Tachypnoea
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Agitation
19%
Oedema peripheral
15%
Hypomagnesaemia
15%
Dyspnoea
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dysphagia
12%
Arthralgia
12%
Peripheral sensory neuropathy
12%
Hypoxia
12%
Vomiting
12%
Covid-19
12%
Aspartate aminotransferase increased
12%
Myalgia
12%
Pain
12%
Hypertension
12%
Hyperglycaemia
12%
Abdominal pain
12%
Malaise
8%
Pancytopenia
8%
Muscular weakness
8%
Encephalopathy
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Dysuria
8%
Eye pain
8%
Asthenia
8%
Hyperhidrosis
8%
Blood creatinine increased
8%
Lymphocyte count decreased
8%
Oral candidiasis
8%
Sepsis
8%
Urinary tract infection
8%
Somnolence
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Depression
4%
Pleural effusion
4%
Embolism
4%
Syncope
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
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 2
~510
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,144 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.