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CAR T-cell Therapy

CAR-T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Led By Jordan Gauthier
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of R/R B-cell NHL or ALL meeting specified criteria
Successful collection of T cells for huJCAR014 manufacturing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first hujcar014 infusion to death, assessed up to 15 years
Awards & highlights

Study Summary

This trial will study the side effects of huJCAR014 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia that have failed other treatments. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces. The trial will be conducted in two stages with the first stage focused on finding the right dose and the second stage focused on safety and efficacy.

Who is the study for?
Adults with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia, who have tried certain treatments like anthracycline and rituximab. They must show CD19 expression on cancer cells, be in good physical condition, have proper organ function, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing huJCAR014 CAR-T cells made from a patient's own T cells that are genetically modified to target CD19 on cancer cells. It includes dose-finding studies for different types of blood cancers and further safety and efficacy tests at selected doses.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, fatigue, changes in blood counts which could lead to infections or bleeding problems. Organ inflammation might also occur due to the targeted nature of the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is relapsed or refractory B-cell NHL or ALL.
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My T cells have been successfully collected for treatment preparation.
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I am 18 years old or older.
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My condition has not improved or has returned after treatment.
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My cancer cells show CD19 presence.
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My bone marrow is working well.
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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first hujcar014 infusion to death, assessed up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first hujcar014 infusion to death, assessed up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve of huJCAR014 cells in blood
Dose-limiting toxicity (DLT) rates
Incidence of toxicity
+3 more
Secondary outcome measures
Complete response (CR) rate
Duration of response (DOR)
Event-free survival (EFS)
+4 more
Other outcome measures
B-cell depletion in circulation
Biopsy
Cellular immune responses to huJCAR014
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (leukapheresis, chemotherapy, huJCAR014)Experimental Treatment6 Interventions
Patients undergo leukapheresis. Beginning 14-16 days after leukapheresis, patients undergo lymphodepleting chemotherapy comprising either cyclophosphamide IV daily for 1 day and fludarabine IV daily for 3 days or cyclophosphamide and fludarabine IV daily for 3 days. Within 36-96 hours after completion of lymphodepleting chemotherapy, patients receive huJCAR014 IV over 20-30 minutes on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Leukapheresis
2016
Completed Phase 2
~690

Find a Location

Who is running the clinical trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry Sponsor
14 Previous Clinical Trials
1,672 Total Patients Enrolled
3 Trials studying Lymphoma
330 Patients Enrolled for Lymphoma
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,190 Total Patients Enrolled
93 Trials studying Lymphoma
6,078 Patients Enrolled for Lymphoma
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,213 Total Patients Enrolled
100 Trials studying Lymphoma
6,482 Patients Enrolled for Lymphoma

Media Library

huJCAR014 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03103971 — Phase 1
Lymphoma Research Study Groups: Treatment (leukapheresis, chemotherapy, huJCAR014)
Lymphoma Clinical Trial 2023: huJCAR014 Highlights & Side Effects. Trial Name: NCT03103971 — Phase 1
huJCAR014 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03103971 — Phase 1

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 able to take part in this experiment?

"Affirmative, according to clinicaltrials.gov the study is actively searching for individuals that meet its criteria. This research was first posted on November 3rd 2017 and has been recently revised as of July 20th 2022. 78 volunteers are needed across a single site."

Answered by AI

Are there still slots available for participants in this investigation?

"This clinical trial is currently enrolling participants, as per the data posted on clinicaltrials.gov. The medical study was initially published in November 2017 and most recently updated in July 2022."

Answered by AI

What risk factors should individuals consider when engaging in Pharmacological Study?

"Due to the limited clinical evidence on safety and efficacy, Pharmacological Study received a score of 1."

Answered by AI

Have any other pharmacological investigations been conducted?

"Presently, there are 889 clinical trials investigating Pharmacological Study; 161 of these studies currently reside in Phase 3. Philadelphia, Pennsylvania is the most frequent city for this type of research with 28446 locations running related experiments."

Answered by AI

What objectives are being sought with this research?

"The primary aim of this 28-day trial is to ascertain the toxicity rate. Secondary goals include determining the partial response (PR) rate, objective response rate (ORR), and duration of response (DOR). PR and ORR will be analysed using a two-sided 95% exact Clopper-Pearson confidence interval based on EE analysis sets; DOR will be evaluated by Kaplan–Meier methodology."

Answered by AI

For what applications is Pharmacological Study typically deployed?

"Pharmacological Study is most often given to individuals with multiple sclerosis, but it can also be prescribed for those living with lymphoma, leukemia, myelocytic diseases and acute or retinoblastoma-related conditions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
2017. "huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03103971.
~7 spots leftby Apr 2025
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