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CAR T-cell Therapy
CAR-T Therapy for Leukemia
Phase 1 & 2
Recruiting
Led By Matthew Foster, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky score > 60% if ≥16 years old, or Lansky performance score of greater than 60% if <16 years old
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is testing a new way to fight cancer by combining two existing methods. Antibodies attach to cancer cells, and T cells kill them. The new treatment, ATLCAR.CD19, is an antibody attached to a T cell. It has shown promise, but causes side effects in some patients.
Who is the study for?
This trial is for people aged 3-70 with relapsed/refractory B cell ALL, who've had some prior treatment. They must have a certain level of health and organ function, agree to contraception methods if applicable, and not be pregnant or breastfeeding. Those with severe infections or other active cancers aren't eligible.Check my eligibility
What is being tested?
The study tests autologous T cells modified with a CD19 antigen (iC9-CAR19 cells) to treat leukemia. It includes an 'off switch' to reduce side effects like cytokine release syndrome. The goal is to find the safest dose that works best against cancer.See study design
What are the potential side effects?
Potential side effects include flu-like symptoms from mild cytokine release syndrome to more serious issues such as neurotoxicity, cardiac arrest, multi-system organ failure, or even death in severe cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly independent in my daily activities.
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I am a man who either had a vasectomy or will use contraception.
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I am between 3-17 years old and weigh at least 10 kg, or I am an adult aged 18-70.
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My T cells have been modified and meet specific quality standards.
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My cancer cells are CD19 positive.
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I am willing to use two forms of birth control or abstain from sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability of iC9-CAR19 T cells
Secondary outcome measures
Changes in patient reported health-related quality of life in adult patients
Changes in patient reported physical functions in adult patients
Changes in persistence of iC9-CAR19 T cells in vivo
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: iC9-CAR19 cellsExperimental Treatment4 Interventions
The 3+3 design in adult subjects and an independent study using 3+3 design in pediatric subjects. The starting dose of 5 x 10^5 transduced cells/kg will enroll 3 adult subjects in the initial cohort. If there are no dose limiting toxicities w/in 4 weeks of the cell infusion in these 3 subjects, then the next cohort will evaluate 1 x10^6 transduced cells/kg in adults. If there is toxicity in 1/3 patients in the initial cohort, the cohort will be expanded to enroll up to 6 adult patients. If the dose level 1 is determined to be above the tolerated cell dose, de-escalation would occur to dose level -1 where subjects would receive 1 x 10^5 transduced cells/kg. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before administration of iC9-CAR19 T cells.
Group II: Expansion Cohort Second Administration of iC9-CAR19 cellsExperimental Treatment4 Interventions
After the recommended phase 2 dose (RP2D) of iC9-CAR19 T cells has been determined in adults, up to 18 additional adult subjects will be enrolled in an expansion cohort at the RP2D. In the expansion cohort, subjects will be offered a second infusion of iC9-CAR19 T cells based on B-cell recovery and minimal residual disease (MRD) status. All subjects will receive a lymphodepleting regimen of fludarabine and cyclophosphamide before second administration of iC9-CAR19 T cells.
Subjects in the expansion cohort who experience ≥grade 2 CRS or ICANS, did not respond to the initial dose of the standard of care treatment will be enrolled in a sub-study of rimiducid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Rimiducid
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,077 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,279 Total Patients Enrolled
Bellicum PharmaceuticalsIndustry Sponsor
27 Previous Clinical Trials
1,298 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except for skin cancer in the last 5 years.My tumor is not located where it could block my airway if it grows.My aggressive leukemia is worsening with over half of my white blood cells being cancerous.I haven't taken experimental drugs or had cancer vaccines in the weeks before my treatment.I am taking a low dose of hydrocortisone or a similar medication.I am mostly independent in my daily activities.I have not received donor lymphocyte infusions within 6 weeks before getting iC9-CAR19 T cell therapy.I haven't received T cell targeting treatments like alemtuzumab in the last 8 weeks.I do not need extra oxygen to maintain my oxygen levels above 90%.I am currently taking 10 mg or more of prednisone daily or its equivalent.I received a specific medication less than 3 weeks before starting my current treatment.I had radiation therapy not aimed at the brain less than a week ago, or brain radiation less than 7 weeks ago.I have Ph+ ALL and have not responded to at least 2 treatments, had a relapse after a stem cell transplant, or have minimal residual disease.I have received blood products to maintain my hemoglobin above 7.0 g/dL and platelets above 20,000.My kidney and liver are functioning well.I am a man who either had a vasectomy or will use contraception.I have stopped any CNS leukemia treatment before starting lymphodepleting chemotherapy.I am taking corticosteroids equivalent to or more than 10 mg/day of prednisone.All my medical records needed for this trial are available.I am between 3-17 years old and weigh at least 10 kg, or I am an adult aged 18-70.I am a woman who can have children and have a recent negative pregnancy test.My leukemia is in remission, meets specific time criteria, and tests positive for CD19.My T cells have been modified and meet specific quality standards.My cancer cells are CD19 positive.I have had a condition where my lymphocytes multiply unusually.I do not have active HIV, hepatitis B, or hepatitis C.I have another cancer that is growing and needs treatment.I am being treated for an infection, but it is under control.I have not had certain cancer treatments in the last 2 weeks.I have not had salvage chemotherapy within the last week.I stopped any GVHD medication more than 3 weeks ago.I am willing to use two forms of birth control or abstain from sex.I am currently on a maintenance dose of chemotherapy.I have a history of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: iC9-CAR19 cells
- Group 2: Expansion Cohort Second Administration of iC9-CAR19 cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have agreed to participate in this clinical research?
"Affirmative. Clinicaltrials.gov records indicate that this medical trial, which was posted on March 22nd 2012, is actively recruiting participants at the moment. 54 people will be admitted to a single site for observation and treatment."
Answered by AI
Would I qualify to be part of this research endeavor?
"This medical trial is seeking 54 participants, aged 3 to 70 years old with an immune system illness. To be eligible they must meet the following conditions: provide written informed consent and HIPAA authorization; have a Karnofsky score >60% or Lansky performance score> 60%; their serum creatinine levels ≤ 1.5 X ULN; total bilirubin ≤ 1.5 X ULN (unless attributed to Gilbert's Syndrome); AST and ALT ≤ 3.0 X ULN; females of childbearing potential must receive a negative pregnancy test within 72 hours prior to procurement; males must either have had vasectomy or"
Answered by AI
What other experiments have been conducted using iC9-CAR19 cells?
"Currently, 901 clinical trials are taking place for iC9-CAR19 cells. Of those active projects, 161 have reached Phase 3 testing. Philadelphia is the centre of many of these studies but there over 28 thousand locations around the world looking into this therapy."
Answered by AI
Does this research endeavor allow adults aged 25 and up to participate?
"This clinical trial is accessible to patients aged between 3 and 70. Additionally, there are 795 studies available for minors under 18 years old, as well as 1,880 studies offered to those over 65."
Answered by AI
Is the research team currently accepting new participants?
"Affirmative. Clinicaltrials.gov states that this trial, which was issued on March 22nd 2012 and recently revised on December 21st 2021, is actively recruiting participants. 54 individuals are needed to be sourced from 1 medical centre."
Answered by AI
To what maladies is the iC9-CAR19 cell line typically utilized to combat?
"iC9-CAR19 is primarily employed to treat multiple sclerosis, though it has been known to help patients with leukemia, myelocytic and acute forms of retinoblastoma and histiocytic lymphoma."
Answered by AI
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