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CAR T-cell Therapy
CAR-T Cell Therapy for Acute Lymphoblastic Leukemia (CAR-20/19-T Trial)
Phase 1
Recruiting
Led By Julie-An Talano, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to give informed consent if > 18 years, or with a legal guardian capable of giving informed consent if < 18 years.
Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, or cytogenetics, or morphological disease in the bone marrow.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights
CAR-20/19-T Trial Summary
This trial will study a new cancer treatment involving CAR-T cells, which are genetically modified to target and destroy cancer cells. The safety and effectiveness of this treatment will be evaluated in patients with B cell acute lymphoblastic leukemia.
Who is the study for?
This trial is for people with B-cell ALL that's come back or hasn't responded to treatment, including those who've tried multiple therapies or had a stem cell transplant. Adults and kids over 1 year old can join if they have good organ function, no serious heart issues, and agree to use birth control. People with allergies to certain animal products, active infections like HIV or hepatitis, severe autoimmune diseases, recent other cancer treatments, or untreated brain involvement by leukemia can't participate.Check my eligibility
What is being tested?
The study tests different doses of CAR-20/19-T cells (a type of immunotherapy) in patients with relapsed/refractory B-cell ALL. It aims to see how safe and effective this therapy is when targeting two specific proteins on cancer cells using a special device for cell processing.See study design
What are the potential side effects?
Potential side effects may include immune reactions where the body attacks its own tissues (autoimmune phenomena), symptoms related to infusion such as fever and chills (infusion reactions), blood disorders due to bone marrow suppression, increased risk of infections, and possibly neurological issues.
CAR-20/19-T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and can consent, or if under 18, I have a guardian who can.
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My cancer can be measured or seen through tests.
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My lungs work well enough, with oxygen levels at or above 92% on room air.
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My B cell ALL has come back or is not responding to treatment.
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My leukemia cells are CD19 or CD20 positive.
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I will need a central line for my CAR-T cell therapy.
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My acute lymphoblastic leukemia is resistant and I've tried at least two specific medications without success.
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My condition did not improve after initial treatment.
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My condition did not improve after at least two treatments.
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I am mostly able to care for myself but may need help.
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My kidney function, measured by creatinine clearance or GFR, is good.
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I use a diaphragm or cervical cap with spermicide for birth control.
CAR-20/19-T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events after CAR 20/19-T Cell Infusion.
Secondary outcome measures
Describe the duration of response for responding patients.
Determine persistence of CAR-20/19-T cells.
Determine the anti-tumor responses as measured by response rates.
+2 moreCAR-20/19-T Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment4 Interventions
The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort. Subjects will receive one of three dose levels. The dose expansion arm will be updated with the appropriate dose in the future based on the escalation results.
Group II: 5 x 10^5 CAR-20/19-T cells/kgExperimental Treatment1 Intervention
The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.
Group III: 2.5 x10^6 CAR-20/19-T cells/kgExperimental Treatment1 Intervention
The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.
Group IV: 1 x10^6 CAR-20/19-T cells/kgExperimental Treatment1 Intervention
The study will utilize a 3+3 dose escalation design in ALL followed by a six-patient expansion cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
2017
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,559 Total Patients Enrolled
Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
96,625 Total Patients Enrolled
Julie-An Talano, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active cancer except for skin cancer or any cancer that has been in remission for over 5 years.I will retake the CD3+ T-cell count test if I receive chemotherapy or steroids before apheresis.I am over 18 and can consent, or if under 18, I have a guardian who can.My acute lymphoblastic leukemia is not worsening quickly.My cancer can be measured or seen through tests.I have no brain abnormalities.My lungs work well enough, with oxygen levels at or above 92% on room air.I am aged 1-70 with B-cell ALL and no curative treatment options left.I do not have advanced brain involvement with my cancer.I haven't had chemotherapy other than for lymphodepletion in the last 14 days.I developed a severe form of lymphoma or leukemia after an organ transplant.My B cell ALL has come back or is not responding to treatment.My leukemia cells are CD19 or CD20 positive.I will need a central line for my CAR-T cell therapy.I have a genetic condition linked to bone marrow failure.I have had CD19 or CD20 therapy and tests show my disease is still CD19 or CD20 positive.You are using hormonal birth control methods.My liver tests are within normal limits or not concerning for my condition.I haven't had chemotherapy or high-dose steroids in the last 2 weeks, and I stopped my TKI medication as required before joining.My acute lymphoblastic leukemia is resistant and I've tried at least two specific medications without success.I have received anti-CD19 antibody treatment within the last month.I have severe side effects from past treatments not caused by my disease.You must use condoms (for males or females) with or without a sperm-killing substance.I have not received anti-CD20 antibody treatment in the last 4 weeks.I don't have major brain disorders or active leukemia in my spinal fluid.I have a serious autoimmune disease or need high doses of steroids for it.Your expected survival is longer than 3 months (12 weeks).I had a stem cell transplant over 100 days ago and haven't taken immunosuppressants for 4 weeks.You have a known allergy to products derived from cows or mice.My condition did not improve after initial treatment.My condition did not improve after at least two treatments.I have HIV or Hepatitis B/C, or a history of these with an undetectable viral load.I have not had a stem cell transplant in the last 100 days, do not have GVHD, and am not on immunosuppression.I am mostly able to care for myself but may need help.My previous brain-related illness was treated over a month ago, and I've shown improvement.My kidney function, measured by creatinine clearance or GFR, is good.I use a diaphragm or cervical cap with spermicide for birth control.
Research Study Groups:
This trial has the following groups:- Group 1: 1 x10^6 CAR-20/19-T cells/kg
- Group 2: 5 x 10^5 CAR-20/19-T cells/kg
- Group 3: 2.5 x10^6 CAR-20/19-T cells/kg
- Group 4: Dose Expansion Phase
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 there opportunities to join this research endeavor currently available?
"This medical trial, which was initially made available on October 16th 2020, is actively seeking participants as per the information found on clinicaltrials.gov. The study's data has been most recently updated on September 22nd 2022."
Answered by AI
Do I meet the criteria to be accepted into this experiment?
"This clinical trial is admitting twenty-four individuals with acute lymphoblastic leukemia who have undergone unsuccessful remission. The age range of participants requires they are somewhere between one year and thirty-nine years old. Furthermore, to be considered viable for inclusion in the study, subjects must meet certain conditions: their bone marrow tests need to demonstrate CD19/20 positivity (at least 5%); B-cell ALL diagnosis; relapse or refractory disease after two or more systemic therapies; relapse and refractoriness post allogeneic transplantation (so long as it has been at least 100 days since stem cell therapy); morphological evidence of disease in"
Answered by AI
Is geriatric participation being accepted in this clinical trial?
"The requirements for admission into this trial set the minimum age at 1 Year, and cap off at 39 Years."
Answered by AI
How many participants are currently partaking in this medical research?
"Confirmed. Clinicaltrials.gov lists this experiment as actively recruiting, beginning with its posting on October 16th 2020 and last edited on September 22nd 2022. The trial requires 24 participants from one location."
Answered by AI
Has the FDA sanctioned CAR-20/19-T cells for therapeutic use?
"Our team at Power believes that, due to its early stage of development and limited data on safety and efficacy, CAR-20/19-T cells can be assessed as safe at a level 1."
Answered by AI
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