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CAR T-cell Therapy
CAR T-Cell Therapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Crystal Mackall
Research Sponsored by Crystal Mackall, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of ALL with no available alternative curative therapies or subject has declined to pursue alternative therapy; must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment
Recurrence of disease after achieving a complete response (CR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Study Summary
This trial will test the efficacy of CD19/CD22-CAR T cells in treating children with B-cell acute lymphoblastic leukemia that has returned or is unresponsive to treatment.
Who is the study for?
This trial is for children and young adults aged 1 to 30 with B-cell acute lymphoblastic leukemia that's resistant or has returned after treatment. They should have tried at least two therapies, be free of uncontrolled infections, not pregnant or breastfeeding, and without severe heart conditions. Participants must also have no history of certain other diseases within the last three years.Check my eligibility
What is being tested?
The study tests different doses of CD19/CD22 CAR T cells combined with chemotherapy (fludarabine phosphate and cyclophosphamide) in patients whose leukemia expresses CD19 proteins. It aims to find the best dose that is effective while monitoring side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, fatigue, headache, drops in blood pressure; organ inflammation; possible worsening of leukemia symptoms; and risks associated with chemotherapy like nausea, hair loss, mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ALL and can't have or don't want a stem cell transplant.
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My cancer came back after it was completely gone.
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My organs and bone marrow are functioning normally.
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I am between 1 and 30 years old.
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I can do most activities myself if I am over 10, or my child can do most activities if they are 10 or under.
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My cancer cells show high levels of CD19.
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I have Ph+ALL and my condition didn't improve after two treatments, including TKIs.
Select...
My B-ALL cancer did not respond to two different treatments.
Select...
My lymphoma didn't improve or returned after treatment with specific drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells
Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA)
Secondary outcome measures
The ability to achieve a clinical response after administration of CD19/CD22 chimeric antigen receptor (CAR) T cells
Other outcome measures
Alterations in early B cell development induced by immune pressure exerted via CD19/CD22-CAR T cells
CD19/CD22 chimeric antigen receptor (CAR) T cell properties
Frequency of CD22+ expression on lymphoma cells
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CD19/CD22-CAR T cells, chemotherapy)Experimental Treatment5 Interventions
Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and cyclophosphamide IV over 60 minutes on day -2. Patients then receive CD19/CD22-CAR T cells IV over 10-20 minutes on day 0. Patients that benefited from the first dose of CD19/CD22-CAR T cells, had no unacceptable side effects, and have enough cells left over may receive 2 or 3 additional doses of CD19/CD22-CAR T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
167 Total Patients Enrolled
Crystal MackallPrincipal Investigator - Stanford University
Stanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have brain disorders that could affect nerve damage assessment.My condition worsened after a stem cell transplant.My minimal residual disease has been confirmed positive twice, at least 4 weeks apart.My ALL has come back or didn't respond to treatment, and is only in my testicles.I have lymphoma or a disease affecting my brain detected through imaging.My white blood cell count is very high or my disease is getting worse quickly.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or carcinoma in situ.I have an infection that isn't controlled or needs IV drugs to manage.I have an ongoing infection with HIV, hepatitis B, or hepatitis C.I have not had serious heart problems in the last year.I have not had an autoimmune disease or primary immunodeficiency in the last 2 years.I have ALL and can't have or don't want a stem cell transplant.My cancer came back after it was completely gone.My organs and bone marrow are functioning normally.My kidney, liver, lung, and heart functions are all within normal ranges.I had a stem cell transplant over 100 days ago, no active GVHD, and haven't taken immunosuppressants for 30 days.I had CAR therapy before, but less than 5% of my T-cells still show the treatment.I am between 1 and 30 years old.I am capable of becoming pregnant and have a negative pregnancy test.It's been over 2 weeks or 5 half-lives since my last systemic therapy before my planned leukapheresis.My CNS status meets the criteria for leukemia or lymphoma.I can do most activities myself if I am over 10, or my child can do most activities if they are 10 or under.My cancer cells show high levels of CD19.My cancer returned to the brain after treatment, and tests confirm it's active.Side effects from my previous treatments are mild or gone.I have Ph+ALL and my condition didn't improve after two treatments, including TKIs.I do not have any health issues that could affect the study's safety or results.I am currently on blood thinners.My B-ALL cancer did not respond to two different treatments.My lymphoma didn't improve or returned after treatment with specific drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CD19/CD22-CAR T cells, chemotherapy)
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.
Are older adults, aged 35 and above, being admitted to this experiment?
"This research project is seeking volunteers between the ages of 1 year and 30 years old."
Answered by AI
Who qualifies to participate in this research trial?
"To be considered, applicants must exhibit minimal residual disease and should range between one year old and 30. The trial organisers are currently looking to accept around 50 candidates into the study."
Answered by AI
How conclusively has Chimeric Antigen Receptor T-Cell Therapy been demonstrated to be without risk?
"Our research team has assigned Chimeric Antigen Receptor T-Cell Therapy a score of 1, as the limited clinical data available indicates it is in the early stages of development and safety testing."
Answered by AI
Is this clinical trial actively seeking participants?
"Clinicaltrials.gov has indicated that this clinical trial is still recruiting participants, with the initial post dating back to October 20th 2017 and the most recent edit being on February 3rd 2022."
Answered by AI
In what medical conditions would a physician likely recommend Chimeric Antigen Receptor T-Cell Therapy?
"Chimeric Antigen Receptor T-Cell Therapy has been identified as a potential treatment for multiple sclerosis, mixed-cell type lymphoma and myelocytic acute leukemia."
Answered by AI
What is the scope of participation for this research investigation?
"Indeed, the listing on clinicaltrials.gov confirms that this medical experiment is actively recruiting participants. Originally posted October 20th 2017 and last updated February 3rd 2022, it seeks to enrol 50 patients from a single site."
Answered by AI
Are there other precedents for Chimeric Antigen Receptor T-Cell Therapy in the scientific literature?
"Currently, 889 clinical trials exploring Chimeric Antigen Receptor T-Cell Therapy are active. Of these, 161 have entered Phase 3 testing. The Philadelphia area is the hub of research for this therapeutic approach; however there are 28446 locations conducting experiments with it around the world."
Answered by AI
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