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CAR T-cell Therapy

lisocabtagene maraleucel for B-Cell Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Juno Therapeutics, a Subsidiary of Celgene

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 from first dose after jcar017 infusion to up to approximately 24 months

Awards & highlights

Study Summary

This trial is testing a new immunotherapy drug, lisocabtagene maraleucel, to see if it is effective and safe in treating adults with aggressive B-cell non-Hodgkin lymphoma who have not responded to other treatments.

Eligible Conditions

B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose after jcar017 infusion to up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose after jcar017 infusion to up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose after jcar017 infusion to up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Change From Baseline of Chemistry Laboratory Results: Alanine Aminotransferase, Aspartate Aminotransferase, Lactate Dehydrogenase

Change From Baseline of Chemistry Laboratory Results: Albumin

Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate

+33 more

Side effects data

From 2022 Phase 2 trial • 74 Patients • NCT03483103

51%

Neutropenia

39%

Fatigue

31%

Anaemia

30%

Thrombocytopenia

25%

Nausea

25%

Cytokine release syndrome

23%

Leukopenia

18%

Hypokalaemia

18%

Hypomagnesaemia

16%

Diarrhoea

16%

Tremor

16%

Hypotension

15%

Oedema peripheral

13%

Cough

13%

Constipation

13%

Dizziness

13%

Insomnia

13%

Lymphopenia

11%

Dyspnoea

11%

Decreased appetite

11%

Headache

10%

Hypertension

10%

Pain in extremity

10%

Confusional state

Fall

Hypogammaglobulinaemia

Vomiting

Asthenia

Neutrophil count decreased

Hyponatraemia

Hypophosphataemia

Anxiety

Pyrexia

Productive cough

Depression

Acute kidney injury

Orthostatic hypotension

Back pain

Lethargy

Pulmonary embolism

Upper gastrointestinal haemorrhage

Muscular weakness

Obstruction gastric

Disorientation

Aphasia

COVID-19

COVID-19 pneumonia

Staphylococcal infection

Stenotrophomonas sepsis

Hip fracture

Neck pain

Lower gastrointestinal haemorrhage

Bacteraemia

Blood bilirubin increased

Weight decreased

Arthralgia

Febrile neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Lisocabtagene Maraleucel (JCAR017)

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Lisocabtagene maraleucel at a dose of 100×10^6 CAR+ T cells (50×10^6 CD8+ CAR+ T cells and 50×10^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

lisocabtagene maraleucel

2018

Completed Phase 2

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor

11 Previous Clinical Trials

1,380 Total Patients Enrolled

Nick Trede, MD, PhDStudy DirectorJuno Therapeutics, Inc.

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,456 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would it be possible to find out how many research centers are participating in this experiment within the city limits?

"There are a total of 41 sites running this study, some notable locations include UNC School of Medicine in Los Angeles, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, and University of Rochester Medical Center in Milwaukee."

Answered by AI

How many people are being recruited for this clinical trial?

"This trial is no longer admitting patients. The clinical trial was initially posted on 7/26/2018 and was last updated on 4/22/2022. For other trials, there are 1867 trials actively admitting participants with lymphoma, diffuse and 8 trials for lisocabtagene maraleucel actively admitting patients."

Answered by AI

What other lisocabtagene maraleucel research projects have been completed?

"lisocabtagene maraleucel was first studied in 2016 at Beth Israel Deaconess Medical Center. Presently, 0 studies have been completed while 8 are actively recruiting participants with a high concentration in Los Angeles, California."

Answered by AI

Does lisocabtagene maraleucel pose any threat to patients?

"Lisocabtagene maraleucel is still being studied in Phase 2 clinical trials, meaning that while there is some data supporting its safety, none yet exists to show that it is an effective medication."

Answered by AI

What are the top three medical conditions that lisocabtagene maraleucel has been proven to improve?

"This therapy can be given to patients that have received two or more prior lines of systemic treatment. Additionally, this novel treatment has been shown to help patients with conditions such as follicular grade 3b lymphoma, high grade b-cell lymphoma (hgbcl), and refractory diffuse large b cell lymphoma (dlbcl)."

Answered by AI

Has this experiment been conducted before?

"Lisocabtagene maraleucel was first studied in 2016 by Juno Therapeutics. 385 patients participated in the initial Phase 1 clinical trial which resulted in drug approval later that year. As of today, 8 ongoing studies are being conducted across 71 cities and 14 countries."

Answered by AI

Are recruitment efforts for this clinical trial ongoing at present?

"This trial is no longer enrolling patients. It was originally posted on 7/26/2018, and the last update to the listing was on 4/22/2022. If you are looking for other studies, there are 1867 lymphoma trials and 8 lisocabtagene maraleucel trials currently recruiting patients."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Lisocabtagene Maraleucel as Second-line Therapy in Adults with Relapsed or Refractory Large B-cell Lymphoma Who Were Not Intended for Haematopoietic Stem Cell Transplantation (PILOT): An Open-label, Phase 2 Study

Sehgal, Alison, Daanish Hoda, Peter A Riedell, Nilanjan Ghosh, Mehdi Hamadani, Gerhard C Hildebrandt, John E Godwin, et al.. 2022. “Lisocabtagene Maraleucel as Second-line Therapy in Adults with Relapsed or Refractory Large B-cell Lymphoma Who Were Not Intended for Haematopoietic Stem Cell Transplantation (PILOT): An Open-label, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00339-4.

The Lancet OncologyJournal

clinicaltrials.govStudy

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

2018. "Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03483103.