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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
Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function
Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to up to 41 months
Awards & highlights

Study Summary

This trial will test a new immunotherapy drug, JCAR017, on patients with aggressive B-cell non-Hodgkin lymphoma who have relapsed from or are refractory to two lines of immunochemotherapy. The study will follow patients for up to 2 years to assess safety, PK, and efficacy of the drug.

Eligible Conditions
  • B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Lymphatic Diseases
  • Lymphoma
  • Lymphoproliferative Disorders
  • Immunoproliferative Disorders
  • Cancer
  • Tumors
  • Non-Hodgkin's Lymphoma
  • Immune Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your bone marrow, kidneys, liver, lungs, and heart are working well.
Select...
You have a type of blood cancer called B-cell NHL, and it has come back or is not responding to treatment. This includes different subtypes of B-cell NHL like diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B. You have already received treatment with certain medications like anthracycline and rituximab, and have tried at least two other types of treatment for DLBCL or had an autologous stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to up to 41 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to up to 41 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
Percentage of Participants With Cytokine Release Syndrome (CRS) Adverse Events Grade ≥ 3
Percentage of Participants With Infection Adverse Events Grade ≥ 3
Percentage of Participants With Neurotoxicity (NT) Adverse Events Grade ≥ 3
+1 more
Secondary outcome measures
Area Under the Blood Concentration-time Curve From Time to Zero to 28 Days After Dosing AUC (0-28)
Complete Response Rate (CRR)
Duration of Response (DoR) and Duration of Complete Response (DoCR)
+19 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%
Constipation
13%
Dizziness
13%
Insomnia
13%
Cough
13%
Lymphopenia
11%
Dyspnoea
11%
Decreased appetite
11%
Headache
10%
Hypertension
10%
Pain in extremity
10%
Confusional state
8%
Vomiting
8%
Asthenia
8%
Hypogammaglobulinaemia
8%
Fall
8%
Neutrophil count decreased
8%
Hyponatraemia
8%
Hypophosphataemia
8%
Anxiety
8%
Pyrexia
7%
Depression
7%
Acute kidney injury
7%
Orthostatic hypotension
7%
Productive cough
7%
Back pain
7%
Lethargy
3%
Pulmonary embolism
3%
Upper gastrointestinal haemorrhage
3%
Muscular weakness
2%
Aphasia
2%
COVID-19
2%
COVID-19 pneumonia
2%
Staphylococcal infection
2%
Stenotrophomonas sepsis
2%
Hip fracture
2%
Neck pain
2%
Lower gastrointestinal haemorrhage
2%
Bacteraemia
2%
Blood bilirubin increased
2%
Weight decreased
2%
Arthralgia
2%
Disorientation
2%
Febrile neutropenia
2%
Obstruction gastric
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lisocabtagene Maraleucel (JCAR017)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lisocabtagene maraleucelExperimental Treatment1 Intervention
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of lisocabtagene maraleucel. During lisocabtagene maraleucel production, subjects may receive low-dose chemotherapy for disease control. Upon successful generation of lisocabtagene maraleucel product, subjects will receive treatment which will include lymphodepleting chemotherapy followed by one dose of lisocabtagene maraleucel administered by intravenous (IV) injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lisocabtagene maraleucel
2018
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,348 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,432 Total Patients Enrolled
Ricardo Espinola, MDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
385 Total Patients Enrolled

Media Library

lisocabtagene maraleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03744676 — Phase 2
B-Cell Lymphoma Research Study Groups: Lisocabtagene maraleucel
B-Cell Lymphoma Clinical Trial 2023: lisocabtagene maraleucel Highlights & Side Effects. Trial Name: NCT03744676 — Phase 2
lisocabtagene maraleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03744676 — Phase 2

Frequently Asked Questions

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

Does lisocabtagene maraleucel have any harmful side effects?

"Lisocabtagene maraleucel's safety is only supported by Phase 2 clinical trial data, so it received a score of 2."

Answered by AI

Is this clinical trial widely available in North America?

"This study is recruiting patients from 34 different centres, which are based in cities such as Wichita, Cincinnati and Salt Lake City. To limit travel-related demands, it would be best to select the site closest to your location."

Answered by AI

What other lisocabtagene maraleucel clinical trials are available for review?

"Lisocabtagene maraleucel is currently being trialled in 8 clinical studies, none of which are Phase 3 trials. Most of the research locations for lisocabtagene maraleucel are based in Boston, Massachusetts; however, there are 299 total clinical trial sites for this medication."

Answered by AI

How has lisocabtagene maraleucel been used to help patients in the past?

"Lisocabtagene maraleucel is often used to treat patients that have already tried 2 or more systemic therapies without success. This medication can also be prescribed to manage refractory diffuse large b cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), and follicular, grade 3b lymphoma."

Answered by AI

What other similar research projects exist for comparison?

"Research into lisocabtagene maraleucel began in 2016. A small, initial study was conducted that year and sponsored by Juno Therapeutics. After the successful completion of this 385-patient trial, lisocabtagene maraleucel received Phase 1 drug approval. As of today, there are 8 ongoing clinical trials being conducted in 71 cities and 14 countries around the world."

Answered by AI

How many people will be included in this clinical research project?

"This research is not actively recruiting new participants at the moment. It was first announced on 11/29/2018 with the latest update being on 7/29/2022. If you're hoping to participate in other studies, 8 trials for lisocabtagene maraleucel are presently admitting patients and 5117 clinical trials involve immune system disorders."

Answered by AI

Are patients still being enrolled in this clinical trial?

"Unfortunately, this particular trial is no longer enrolling patients. Originally posted on November 29th, 2018, the study was last updated on July 29th, 2022. However, there are 5117 other studies currently looking for participants with immune system disorders and 8 different trials involving lisocabtagene maraleucel that are still recruiting patients."

Answered by AI
~16 spots leftby Mar 2025