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CAR T-cell Therapy

JCAR017 for Chronic Leukemia or Lymphoma

Phase 1 & 2
Recruiting
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
Confirmation of CD19-positive disease if prior CD19-targeted therapy has been administered
Diagnosis of SLL with lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL
Must not have
Subjects with Richter's transformation
Presence of acute or extensive chronic graft versus host disease (GVHD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months post treatment
Awards & highlights

Summary

This trial tests JCAR017, a therapy using modified immune cells, in adults with hard-to-treat CLL or SLL. It aims to see if these enhanced immune cells can better fight the cancer.

Who is the study for?
Adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have failed multiple prior therapies can join. Participants must have adequate organ and bone marrow function, not be pregnant, and cannot have active infections like hepatitis B/C or HIV.
What is being tested?
The trial is testing JCAR017 alone or in combination with either ibrutinib or venetoclax to treat CLL/SLL. It's a multi-phase study starting with finding the right dose of JCAR017 before moving on to test its effectiveness and safety at that dose.
What are the potential side effects?
Potential side effects include reactions related to gene therapy, infection risks due to weakened immune system, liver problems, kidney issues, breathing difficulties, heart complications from chemotherapy drugs used alongside JCAR017.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is CD19 positive, even after CD19-targeted treatment.
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I have SLL with specific symptoms and a certain level of B lymphocytes.
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I have tried and not responded to BTK inhibitor treatment or was deemed ineligible for it.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am suitable for or already have a central or peripheral line for blood filtering procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition has progressed to Richter's transformation.
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I am experiencing severe symptoms from a transplant rejection.
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I have a significant brain or nervous system condition.
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My cancer has spread into blood vessels.
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I have unmanaged blood clots in my veins.
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I am not taking any strong medication that affects liver enzymes with my current cancer treatment.
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I have had another type of cancer in the last 2 years.
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My cancer has spread to my brain or spinal cord.
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I have received gene therapy before.
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I do not have active hepatitis B, C, or HIV.
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I do not have any untreated infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm
+7 more
Secondary study objectives
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR)
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR)
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood
+44 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 2 JCAR017 monotherapyExperimental Treatment1 Intervention
Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm
Group II: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)Experimental Treatment1 Intervention
Subjects will receive JCAR017 monotherapy
Group III: Phase 1 JCAR017 monotherapyExperimental Treatment1 Intervention
Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)
Group IV: Phase 1 JCAR017 + venetoclaxExperimental Treatment2 Interventions
Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.
Group V: Phase 1 JCAR017 + ibrutinibExperimental Treatment1 Intervention
Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib

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
Chimeric Antigen Receptor (CAR) T-cell therapy is a cutting-edge treatment for lymphoma that involves modifying a patient's own T-cells to express receptors specific to cancer cells. These engineered T-cells are then infused back into the patient, where they can recognize and attack lymphoma cells. This therapy is significant for lymphoma patients because it offers a targeted approach that can lead to durable remissions, especially in cases where the disease is refractory or has relapsed after conventional treatments. The ability of CAR T-cells to specifically target and destroy cancer cells while sparing normal cells represents a major advancement in lymphoma treatment.

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,113 Total Patients Enrolled
5 Trials studying Lymphoma
593 Patients Enrolled for Lymphoma
Heidi Gillenwater, MDStudy DirectorJuno Therapeutics, Inc.
3 Previous Clinical Trials
387 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,396 Total Patients Enrolled
55 Trials studying Lymphoma
10,519 Patients Enrolled for Lymphoma

Media Library

JCAR017 (lisocabtagene maraleucel) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03331198 — Phase 1 & 2
Lymphoma Research Study Groups: Phase 1 JCAR017 + ibrutinib, Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME), Phase 1 JCAR017 + venetoclax, Phase 2 JCAR017 monotherapy, Phase 1 JCAR017 monotherapy
Lymphoma Clinical Trial 2023: JCAR017 (lisocabtagene maraleucel) Highlights & Side Effects. Trial Name: NCT03331198 — Phase 1 & 2
JCAR017 (lisocabtagene maraleucel) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03331198 — Phase 1 & 2
~102 spots leftby Nov 2027
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