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CAR T-cell Therapy

JCAR017 for Pediatric Leukemia and Lymphoma

Q: What is the population size of this experiment?

In order to successfully complete the clinical trial, 121 qualified participants are required. Those interested in participating can do so at either Local Institution - 168 in Wauwatosa, <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> or Local Institution - 160 located within <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City.

Q: What ailments are commonly treated with the aid of JCAR017?

JCAR017 is a viable treatment for <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, acute <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic disorders and retinoblastoma.

Q: Has JCAR017 been the focus of any other research efforts?

The first JCAR017 trial was conducted back in 1997 at the City of Hope Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center. Since then, 1275 trials have been concluded and 895 are still ongoing with a major concentration located in Wauwatosa, <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a>.

Q: What goals are researchers trying to accomplish with this research endeavor?

Celgene, the sponsor of this trial, has specified that their primary goal (measured over a period not exceeding 56 days) is to determine an appropriate Recommended Phase 2 Dose of JCAR017. Additionally, secondary objectives have been set which include assessing Pharmacokinetics - AUC (Area Under Curve), monitoring Adverse Events and Serious Adverse Events for abnormalities in clinical/histological/molecular subgroups, as well as calculating Event-free Survival from initial infusion till progression or death whichever occurs first.

Q: Are there available slots for participants in this experiment?

Affirmative. Information on clinicaltrials.gov affirms that this medical trial is open for enrollment, having been first posted on October 17th 2018 and last modified on October 24 2022. A total of 121 participants are needed across 18 separate testing sites.

Q: Are there any institutions conducting this research experiment within our state?

Currently, 18 clinical sites around the nation are enrolling participants. Specifically, there is a presence in Wauwatosa, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> and Dallas with other locations present as well. To reduce any travel complications resulting from enrollment, it is advised to select the closest clinic possible.

Phase 1 & 2

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 2: Subject ≤ 25 years of age and weighs ≥ 6 kg at the time of signing the ICF/IAF.

Subject has a Karnofsky score of ≥ 50 (subjects ≥ 16 years of age) or a Lansky score ≥ 50 (subjects < 16 years of age).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days after jcar017 infusion

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating pediatric leukemia and lymphoma. The first part of the trial will test different doses to see what is safe. The second part will test how well the drug works in treating the disease.

Who is the study for?

This trial is for children and young adults up to 25 years old with B-cell Acute Lymphoblastic Leukemia (B-ALL) or Non-Hodgkin Lymphoma (B-NHL) that has come back or hasn't responded to treatment. They must have a certain level of organ function, no history of other cancers in the last 2 years, not be pregnant or nursing, and agree to use contraception.Check my eligibility

What is being tested?

The study tests JCAR017's safety and effectiveness in treating r/r B-ALL and B-NHL. It includes two phases: Phase 1 determines the safest dose for Phase 2, which then assesses how well it works across different disease groups using a specific study design.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, infusion-related reactions; organ inflammation; blood cell count changes; increased risk of infections; neurological events like seizures or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 25 years old or younger and weigh at least 6 kg.

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I am mostly able to care for myself and carry out daily activities.

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I have been diagnosed with B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma.

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My cancer cells show CD19 presence.

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I am 25 years old or younger and weigh at least 6 kg.

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I am under 18 years old and weigh at least 6 kg.

Select...

I am mostly able to care for myself and carry on normal activities.

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I have good veins for blood collection procedures.

Select...

I am under 18 years old and weigh at least 6 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days after jcar017 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days after jcar017 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days after jcar017 infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Minimal residual disease (MRD) negative rate - Cohort 2

Overall response rate (ORR)- Cohort 1

Overall response rate (ORR)- Cohort 3

+1 more

Secondary outcome measures

Adverse Events (AEs)

Best Overall Response (BOR)

Duration of response (DOR)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of JCAR017Experimental Treatment4 Interventions

Subjects will receive Lymphodepleting chemotherapy with intravenous (IV) fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide IV (300 mg/m2/day for 3 days) (flu/cy) concurrently, followed by JCAR017 cells infusion. Phase 1 will evaluate up to 5 JCAR017 cells dose levels and dose escalation/de-escalation will follow a modified toxicity probability interval (mTPI-2) algorithm. The declared RP2D in Phase 1 will be applied to the subjects enrolled in Phase 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

JCAR017

2018

Completed Phase 3

~360

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,850 Total Patients Enrolled

Ettore Biagi, MD, PhDStudy DirectorCelgene

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,876 Total Patients Enrolled

Media Library

JCAR017 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03743246 — Phase 1 & 2

Frequently Asked Questions

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

What is the population size of this experiment?

"In order to successfully complete the clinical trial, 121 qualified participants are required. Those interested in participating can do so at either Local Institution - 168 in Wauwatosa, Wisconsin or Local Institution - 160 located within New york City."

Answered by AI

What ailments are commonly treated with the aid of JCAR017?

"JCAR017 is a viable treatment for multiple sclerosis, acute leukemia, myelocytic disorders and retinoblastoma."

Answered by AI

Has JCAR017 been the focus of any other research efforts?

"The first JCAR017 trial was conducted back in 1997 at the City of Hope Comprehensive Cancer Center. Since then, 1275 trials have been concluded and 895 are still ongoing with a major concentration located in Wauwatosa, Wisconsin."

Answered by AI

What goals are researchers trying to accomplish with this research endeavor?

"Celgene, the sponsor of this trial, has specified that their primary goal (measured over a period not exceeding 56 days) is to determine an appropriate Recommended Phase 2 Dose of JCAR017. Additionally, secondary objectives have been set which include assessing Pharmacokinetics - AUC (Area Under Curve), monitoring Adverse Events and Serious Adverse Events for abnormalities in clinical/histological/molecular subgroups, as well as calculating Event-free Survival from initial infusion till progression or death whichever occurs first."

Answered by AI

Are there available slots for participants in this experiment?

"Affirmative. Information on clinicaltrials.gov affirms that this medical trial is open for enrollment, having been first posted on October 17th 2018 and last modified on October 24 2022. A total of 121 participants are needed across 18 separate testing sites."

Answered by AI

Are there any institutions conducting this research experiment within our state?

"Currently, 18 clinical sites around the nation are enrolling participants. Specifically, there is a presence in Wauwatosa, New york and Dallas with other locations present as well. To reduce any travel complications resulting from enrollment, it is advised to select the closest clinic possible."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)

2018. "A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03743246.

All > Acute Lymphocytic Leukemia > All