lisocabtagene maraleucel for Immune System Disorders

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Immune System Disorders+11 More
lisocabtagene maraleucel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Immune System Disorders
  • Lymphoproliferative Disorders
  • Lymphoma
  • Lymphatism
  • Lymphoma, Diffuse
  • Lymphoma, B-Cell
  • Neoplasms by Histologic Type
  • Cancer
  • Lymphoma, Large B-Cell, Diffuse
  • Immunoproliferative Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Immune System Disorders

Study Objectives

0 Primary · 12 Secondary · Reporting Duration: Through Month 24

Through Month 24
Adverse Events
Adverse events
Complete response (CR) rate
Duration of response (DOR) and duration of complete response (DoCR)
Health economics and outcomes research
Health-related quality of life questionnaires
Objective response rate (ORR)
Overall Survival (OS)
Pharmacokinetics- Maximum concentration (Cmax)
Pharmacokinetics- Time of the maximum concentration (Tmax)
Pharmacokinetics- area under the curve
Progression-free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Immune System Disorders

Trial Design

1 Treatment Group

Lisocabtagene maraleucel
1 of 1
Experimental Treatment

41 Total Participants · 1 Treatment Group

Primary Treatment: lisocabtagene maraleucel · No Placebo Group · Phase 2

Lisocabtagene maraleucel
Biological
Experimental Group · 1 Intervention: lisocabtagene maraleucel · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through month 24

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,555 Total Patients Enrolled
Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,211 Total Patients Enrolled
Ricardo Espinola, MDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
385 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Individuals who have been treated with CD19-targeted therapy in the past must have a biopsy to confirm that their lymphoma is still CD19-positive.
Positron-emission tomography (PET) is a medical imaging technique that produces a three-dimensional image of the inside of an object using positrons
People with relapsed or refractory B-cell non-Hodgkin's lymphoma, of any of the following histologies - diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and diffuse large B-cell lymphoma histology, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B - are eligible for this trial
People who take part in this study have to agree to use contraception that is appropriate for them.
A person with an Eastern Cooperative Oncology Group performance status of 0 to 1 is cancer-free or has only a very mild form of cancer.
You have adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function.
is required It is necessary to have appropriate vascular access in order to perform a leukapheresis procedure.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.