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CAR T-cell Therapy

Modified T Cell Therapy for Non-Hodgkin's Lymphoma

Phase 1
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
PET-positive disease by Lugano classification
Relapsed or refractory B-cell NHL, including DLBCL cohort (no longer enrolling): DLBCL, not otherwise specified (NOS; includes transformed DLBCL from indolent histology [tDLBCL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (Swerdlow 2016), 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 lines of systemic therapy or after auto-HSCT.
Must not have
Uncontrolled systemic fungal, bacterial, viral, or other infection
Presence of graft-vs-host disease (GVHD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests JCAR017, a therapy that modifies a patient's immune cells to fight cancer, in adults with difficult-to-treat non-Hodgkin's lymphoma. The study aims to find the safest and most effective way to use this therapy. JCAR017 has shown potential in treating non-Hodgkin's lymphoma.

Who is the study for?
Adults over 18 with B-cell non-Hodgkin's lymphoma that has returned or didn't respond to treatment can join. They must have had at least two prior treatments, be in good health overall, and not pregnant. People who've had certain recent cancer therapies or infections, other cancers within the last two years (with some exceptions), or active hepatitis or HIV are excluded.
What is being tested?
The trial is testing JCAR017, a modified T cell therapy for lymphoma. Patients will receive either one dose or a two-dose schedule of this treatment to see how safe it is and how well it works against their cancer.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells while targeting cancer cells, which could affect different organs. There might also be typical symptoms from infusion like fever and chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PET scan shows active cancer.
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I have a specific type of B-cell lymphoma and my previous treatments, including anthracycline and rituximab, did not work.
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I have MCL that has not improved after at least 2 treatments, including specific drugs.
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I am fully active or can carry out light work.
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I have suitable veins for a blood filtering procedure.
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I have had CD19-targeted therapy and my biopsy confirms CD19-positive lymphoma.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any untreated serious infections.
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I have graft-vs-host disease.
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I have a significant brain-related condition.
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I haven't taken certain strong chemotherapy drugs in the last 2 weeks.
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I have a history of heart disease.
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My cancer has spread into blood vessels or caused clots.
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I have a blood clot that isn't being managed with stable blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicities of JCAR017
Objective response rate (ORR)
Treatment-related adverse events (AEs) as assessed by CTCAE v4.03
Secondary study objectives
Area-under-the-concentration-vs-time-curve (AUC) in the peripheral blood
Complete response (CR) rate
Duration of response
+5 more

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
Group I: JCAR017 2-dose schedule (no longer accruing)Experimental Treatment1 Intervention
Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 2 intravenous (IV) injections
Group II: JCAR017 1-dose scheduleExperimental Treatment1 Intervention
Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 1 intravenous (IV) injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JCAR017 (lisocabtagene maraleucel) single-dose schedule
2016
Completed Phase 1
~390
JCAR017 (lisocabtagene maraleucel) 2-dose schedule
2016
Completed Phase 1
~390

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, immunotherapy, and hematopoietic cell transplantation. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers to inhibit their growth. Immunotherapy, including CAR-T cell therapy like JCAR017, involves modifying a patient's T cells to better recognize and attack cancer cells. This is particularly significant for NHL patients as it offers a personalized treatment approach that can lead to more effective and sustained responses, especially in relapsed or refractory cases. Understanding these mechanisms helps patients and doctors make informed decisions about the most appropriate and potentially effective treatment options.

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,046 Total Patients Enrolled
Ana Kostic, MDStudy DirectorJuno Therapeutics, Inc.
1 Previous Clinical Trials
64 Total Patients Enrolled
Ricardo Espinola, MDStudy DirectorJuno Therapeutics, Inc.
1 Previous Clinical Trials
104 Total Patients Enrolled

Media Library

JCAR017 (lisocabtagene maraleucel) 2-dose schedule (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02631044 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: JCAR017 2-dose schedule (no longer accruing), JCAR017 1-dose schedule
Non-Hodgkin's Lymphoma Clinical Trial 2023: JCAR017 (lisocabtagene maraleucel) 2-dose schedule Highlights & Side Effects. Trial Name: NCT02631044 — Phase 1
JCAR017 (lisocabtagene maraleucel) 2-dose schedule (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02631044 — Phase 1
~39 spots leftby Dec 2025