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CAR T-cell Therapy

JCAR017 for Chronic Leukemia or Lymphoma

Q: How many participants are receiving care in this investigation?

Unfortunately, recruitment for this research has closed. The clinical trial was initially listed on the 27th November 2017 and updated lastly on 18 October 2022. However, if you are still looking to partake in a medical study there are currently 2861 studies admitting patients with <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>-related afflictions and 349 trials involving JCAR017 (lisocabtagene maraleucel) + <a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a> actively recruiting participants.

Q: What is the ultimate goal of this research endeavor?

As reported by Juno Therapeutics, which is a subsidiary of Celgene Corporation, the primary objective measured over 48 months will be Phase 1 JCAR017 and <a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a> combination dose escalation therapy arm: laboratory abnormalities. Other secondary endpoints include Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR), Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities, and Phase1JCAR017andvenetoclaxcombinationdoseexpansiontherapyarm:MRD-negativeresponserateinperipheralblood.

Q: Are there any open slots still available to join this research initiative?

This clinical trial has already concluded its recruitment process, with posts being made on the November 27th 2017 and last updates from October 18th 2022. For those seeking to participate in other studies, there are presently 2861 trials actively looking for patients suffering from <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> or lymphocytic chronic B-cell conditions, as well as 349 investigations concerning JCAR017 (lisocabtagene maraleucel) + <a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a> searching for participants.

Q: How many healthcare facilities are participating in this research endeavor?

This clinical trial has 42 operating centres, including Local Institution - 0062 in Detroit, Local Institution - 0077 in New Brunswick, and Local Institution - 0010in San Francisco. The other 39 sites are situated across the nation.

Q: Could you provide an overview of the research conducted on the combination therapy of JCAR017 (lisocabtagene maraleucel) with ibrutinib?

As of now, there are 349 separate studies looking into the potential therapeutic benefits of JCAR017 (lisocabtagene maraleucel) + <a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a>. 45 trials have already reached Phase 3 and with 11939 research centres located across Edmonton, Alberta alone, these investigations will likely continue for a while longer.

Q: What applications is the JCAR017 (lisocabtagene maraleucel) + ibrutinib combination commonly employed for?

The combination of JCAR017 (lisocabtagene maraleucel) and <a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a> may be used to address <a href="https://www.withpower.com/clinical-trials/mantle-cell-lymphoma">mantle cell lymphoma</a>, refractory diffuse large b-cell lymphoma, and other diseases for which patients have had two or more lines of systemic therapy.

Phase 1 & 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months post treatment

Awards & highlights

Study Summary

This trial is testing a new drug, JCAR017, to see if it is safe and effective at treating leukemia in adults. The trial will be conducted in two parts, with a separate cohort testing the drug in combination with ibrutinib or venetoclax. All subjects will be monitored for safety and efficacy, and the pharmacokinetics of JCAR017 will be studied.

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.Check my eligibility

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.See study design

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

Select...

My cancer is CD19 positive, even after CD19-targeted treatment.

Select...

I have SLL with specific symptoms and a certain level of B lymphocytes.

Select...

I have tried and not responded to BTK inhibitor treatment or was deemed ineligible for it.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

I am suitable for or already have a central or peripheral line for blood filtering procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months post treatment

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

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

Primary outcome measures

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

+6 more

Secondary outcome measures

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

+34 more

Trial Design

4Treatment 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 1 JCAR017 monotherapyExperimental Treatment1 Intervention

Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)

Group III: 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 IV: 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor

11 Previous Clinical Trials

1,245 Total Patients Enrolled

5 Trials studying Lymphoma

649 Patients Enrolled for Lymphoma

Heidi Gillenwater, MDStudy DirectorJuno Therapeutics, Inc.

3 Previous Clinical Trials

341 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,321 Total Patients Enrolled

53 Trials studying Lymphoma

10,201 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 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

Frequently Asked Questions

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

How many participants are receiving care in this investigation?

"Unfortunately, recruitment for this research has closed. The clinical trial was initially listed on the 27th November 2017 and updated lastly on 18 October 2022. However, if you are still looking to partake in a medical study there are currently 2861 studies admitting patients with leukemia-related afflictions and 349 trials involving JCAR017 (lisocabtagene maraleucel) + ibrutinib actively recruiting participants."

Answered by AI

What is the ultimate goal of this research endeavor?

"As reported by Juno Therapeutics, which is a subsidiary of Celgene Corporation, the primary objective measured over 48 months will be Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities. Other secondary endpoints include Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR), Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities, and Phase1JCAR017andvenetoclaxcombinationdoseexpansiontherapyarm:MRD-negativeresponserateinperipheralblood."

Answered by AI

Are there any open slots still available to join this research initiative?

"This clinical trial has already concluded its recruitment process, with posts being made on the November 27th 2017 and last updates from October 18th 2022. For those seeking to participate in other studies, there are presently 2861 trials actively looking for patients suffering from leukemia or lymphocytic chronic B-cell conditions, as well as 349 investigations concerning JCAR017 (lisocabtagene maraleucel) + ibrutinib searching for participants."

Answered by AI

How many healthcare facilities are participating in this research endeavor?

"This clinical trial has 42 operating centres, including Local Institution - 0062 in Detroit, Local Institution - 0077 in New Brunswick, and Local Institution - 0010in San Francisco. The other 39 sites are situated across the nation."

Answered by AI

Could you provide an overview of the research conducted on the combination therapy of JCAR017 (lisocabtagene maraleucel) with ibrutinib?

"As of now, there are 349 separate studies looking into the potential therapeutic benefits of JCAR017 (lisocabtagene maraleucel) + ibrutinib. 45 trials have already reached Phase 3 and with 11939 research centres located across Edmonton, Alberta alone, these investigations will likely continue for a while longer."

Answered by AI

What applications is the JCAR017 (lisocabtagene maraleucel) + ibrutinib combination commonly employed for?

"The combination of JCAR017 (lisocabtagene maraleucel) and ibrutinib may be used to address mantle cell lymphoma, refractory diffuse large b-cell lymphoma, and other diseases for which patients have had two or more lines of systemic therapy."

Answered by AI

Recent research and studies

BloodJournal

Phase 1 TRANSCEND CLL 004 Study of Lisocabtagene Maraleucel in Patients with Relapsed/refractory CLL or SLL

Siddiqi, Tanya, Jacob D. Soumerai, Kathleen A. Dorritie, Deborah M. Stephens, Peter A. Riedell, Jon Arnason, Thomas J. Kipps, et al.. 2022. “Phase 1 TRANSCEND CLL 004 Study of Lisocabtagene Maraleucel in Patients with Relapsed/refractory CLL or SLL”. Blood. American Society of Hematology. doi:10.1182/blood.2021011895.

CytotherapyJournal

Developing Lisocabtagene Maraleucel Chimeric Antigen Receptor T-cell Manufacturing for Improved Process, Product Quality and Consistency Across CD19+ Hematologic Indications

Teoh, Jeffrey, and Lauren F. Brown. 2022. “Developing Lisocabtagene Maraleucel Chimeric Antigen Receptor T-cell Manufacturing for Improved Process, Product Quality and Consistency Across CD19+ Hematologic Indications”. Cytotherapy. Elsevier BV. doi:10.1016/j.jcyt.2022.03.013.

clinicaltrials.govStudy

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

2017. "Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03331198.

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