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CAR T-cell Therapy
CD22-CAR for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Nirali N Shah, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
-Cardiac function: Left ventricular ejection fraction greater than or equal to 45% or fractional shortening greater than or equal to 28%.
-Pulmonary function: Patients without respiratory symptoms (e.g. dyspnea at rest, known requirement for supplemental oxygen therapy) and who have an oxygen saturation greater than or equal to 92% on room air, will be eligible. For patients not meeting this criteria, pulmonary function tests will be performed to confirm that the DLCO/VA/Adj is 50% of the normal predicted value corrected for hemoglobin and alveolar volume in order to meet eligibility.(For children who are unable to cooperate for PFTs, the criterion is: No evidence of dyspnea at rest, no exercise intolerance and no requirement for supplemental oxygen therapy.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 3 months and 6 months following car infusion
Awards & highlights
Study Summary
This trial is testing whether giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective.
Who is the study for?
This trial is for young people aged 1-39 with B cell ALL or lymphoma that hasn't been cured by standard treatments. They must have tried at least two prior therapies and not be eligible for a stem cell transplant, or it failed. Their cancer cells need to show CD22 protein, they should have measurable disease, and their major organs must function well. Pregnant individuals can't join.Check my eligibility
What is being tested?
The study tests anti-CD22 CAR T-cells in children and young adults with recurrent or resistant blood cancers. Participants will undergo screening, receive chemotherapy over four days, then get the modified T-cells via IV. They'll stay hospitalized until side effects are managed and will be followed up for 15 years.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, fatigue, changes in blood pressure or heart rate; neurological issues like confusion; low blood counts leading to increased infection risk; organ inflammation; and potential long-term complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well, meeting the required efficiency.
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I don't have breathing problems and my oxygen level is at least 92% without extra oxygen.
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I am between 6 and 10 years old with a creatinine level at or below 1.0mg/dL.
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My kidney function is good, with creatinine under 1.2mg/dL.
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I am between 3 and 39 years old and weigh at least 14.5 kg.
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My cancer can be measured or detected using specific tests.
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My kidney function is normal, based on creatinine levels or clearance.
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My child's kidney function is normal, with a creatinine level at or below 0.8mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month, 3 months and 6 months following car infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 3 months and 6 months following car infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response
Toxicity
Secondary outcome measures
CAR-T cell Persistence
Objective Response (Complete + Partial Remission)
Safety and Toxicity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
dose expansion of CD22-CAR
Group II: Arm 1Experimental Treatment1 Intervention
dose escalation of CD22-CAR
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,731 Total Patients Enrolled
Nirali N Shah, M.D.Principal InvestigatorNational Cancer Institute (NCI)
13 Previous Clinical Trials
2,406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received an infusion less than 30 days ago.My heart pumps well, meeting the required efficiency.I have not taken immunosuppressive drugs in the last 30 days.I received a donor lymphocyte infusion less than 6 weeks ago.I've had CAR T-cell therapy before, but less than 5% of those cells are in my blood now.My blood counts are within normal ranges.I have recently undergone treatment.I have recovered from any side effects of my previous specific cancer treatments.I had radiation therapy less than 3 weeks ago, except for apheresis.I have had CAR therapy or similar treatments before apheresis.I have had cancer before, but it was treated over two years ago and is now in remission, except for cervical cancer in situ.I do not have any uncontrolled illnesses that could interfere with the study.My low blood cell counts are due to my condition, not other causes.I don't have breathing problems and my oxygen level is at least 92% without extra oxygen.I am between 6 and 10 years old with a creatinine level at or below 1.0mg/dL.My liver is working well.I had a stem cell transplant from a donor before.I have B cell ALL or lymphoma that hasn't responded to at least two treatments and can't undergo or have refused a stem cell transplant.I had a transplant less than 100 days ago.I am currently experiencing symptoms of graft-versus-host disease.I am 16 or older and can do most activities, or I am under 16 and can do most activities for my age.My cancer cells show a high level of CD22.My kidney function is good, with creatinine under 1.2mg/dL.I do not have HIV, HBV, or HCV infections.I am between 3 and 39 years old and weigh at least 14.5 kg.My cancer can be measured or detected using specific tests.You have had a serious allergic reaction to similar medicines or substances used in this study.My organs are functioning well.I haven't had chemotherapy or cancer drugs for at least 2 weeks, 6 for certain drugs.My white blood cell count is not above 50,000, and my disease is not worsening quickly.I am HIV positive.My kidney function is normal, based on creatinine levels or clearance.My child's kidney function is normal, with a creatinine level at or below 0.8mg/dL.I have a brain condition but it meets the study's specific exceptions.I am not pregnant or breastfeeding.I do not have active brain or spinal cord lymphoma that needs radiation therapy.I had radiation therapy that treated less than 10% of my bone marrow and have measurable disease outside the treated area.My blood has at least 5% CAR T cells as shown by a test.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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.
What are the security measures associated with CD22-CAR treatments?
"Since this is an early stage clinical trial, there is scant evidence to support the safety and efficacy of CD22-CAR. As a result, it was given a score of 1."
Answered by AI
Who would be the ideal candidates for participating in this scientific research?
"This clinical trial is presently enrolling 208 patients with lymphoma, follicular aged 3 to 39. In order to qualify for the study, applicants must meet a range of eligibility criteria including weight and age restrictions; presence or absence of specific central nervous system (CNS) diseases; and having an active B-cell acute lymphoblastic leukemia (ALL) or any form of relapsed/refractory lymphomas that have not responded to standard chemotherapy regimens and salvage treatments. Furthermore, if deemed appropriate by the principal investigator or primary oncologist, there should be no available curative therapies in view before enrollment can take place. Lastly"
Answered by AI
How many individuals are partaking in this experiment?
"Affirmative. The information hosted on clinicaltrials.gov suggests that the research team is actively hunting for participants in this study, which was first posted to the website back on December 12th 2014 and was recently edited November 24th 2022. This trial requires 208 patients between two locations."
Answered by AI
Is this clinical trial still searching for participants?
"Affirmative. Information found on clinicaltrials.gov indicates that this medical experiment, which was initially listed in December 2014, is currently enrolling patients. A total of 208 individuals must be recruited from two separate research sites."
Answered by AI
Is this research endeavor recruiting participants fifty years and older?
"This research seeks participants aged 3 and above, but younger than 39 years old."
Answered by AI
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