Your session is about to expire
← Back to Search
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 12 months
Awards & highlights
Study 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.Check my eligibility
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 ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of toxicities,dose limiting toxicity (DLT) of a second dose of AxiCel (Axi-Cel2) in adults with relapsed/refractory high-risk LBCL.
Secondary outcome measures
Progression free survival (PFS)
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%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
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
2015
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,330 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Phase 1b attained FDA authorization?
"Our team at Power's assessment of the safety of Phase 1b was a score of 1, as this is an early-stage trial with sparse data supporting efficacy and robustness."
Answered by AI
Is this research still open to participants?
"Clinicaltrials.gov confirms that this clinical trial, posted on May 1st 2023 and last edited March 20th 2023 is no longer recruiting patients at the present time. However, there are currently 1750 other studies actively enrolling individuals."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger