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CAR T-cell Therapy
CD22 CAR T Cell Therapy for Hairy Cell Leukemia
Phase 1
Recruiting
Led By Robert J Kreitman, 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
- Serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR or measured
Must not have
- Seropositive for HIV antibody. (Participants with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy in the future should study results indicate effectiveness.)
HIV/HBV/HCV Infection:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every year for 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether it is safe to give anti-CD22 CAR T cells to people with hairy cell leukemia (HCL).
Who is the study for?
Adults over 18 with hairy cell leukemia (HCL) who have tried, can't receive, or refused other treatments. They must meet specific health criteria like normal organ function tests and not be pregnant or breastfeeding. Participants need to agree to use contraception and sign a consent form.
What is being tested?
The trial is testing the safety of anti-CD22 CAR T cells in treating HCL. It involves screening tests, chemotherapy drugs infusion, followed by the experimental CAR T cell infusion, with hospital stay and follow-ups for up to 15 years.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue, complications from low blood counts like infections or bleeding, and possible toxicities affecting organs due to the engineered T cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
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My bone scans show worsening bone damage.
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I have an enlarged spleen causing symptoms.
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I am older than 18 years.
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My cancer is confirmed as HCL or HCLv by specific tests.
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My diagnosis of hairy cell leukemia is confirmed by specific tests.
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My cancer cells show high CD22 levels.
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I have a growing mass or bone lesion larger than 2cm.
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My kidney function is within the required range.
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Over 80% of my cancer cells show CD22.
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I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive.
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I do not have HIV, HBV, or HCV infections.
Select...
I do not have any severe illnesses that my doctor thinks could make participating unsafe for me.
Select...
I am currently taking warfarin.
Select...
I haven't had CAR therapy in the last 30 days or have no lasting CAR T-cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every year for 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every year for 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
antitumor effect
safety and feasibility
Secondary study objectives
MRD negative CR
duration of response
event free survival
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Experimental therapy: Dose ExpansionExperimental Treatment1 Intervention
Autologous anti-CD22-CAR T-cells at the MTD
Group II: Experimental therapy: Dose EscalationExperimental Treatment1 Intervention
Escalating doses of autologous anti-CD22-CAR T-cells in subjects to determine the MTD
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,112 Total Patients Enrolled
Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
12 Previous Clinical Trials
2,356 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the normal range.I do not have HIV, HBV, or HCV infections.I am HIV positive.I can do most of my daily activities unless my illness prevents me.I have tested positive for hepatitis B or C, but if I later test negative, I can still participate.My bone scans show worsening bone damage.I have an enlarged spleen causing symptoms.I had a stem cell transplant over 100 days ago, have no active GVHD, and haven't taken immunosuppressants for 30 days.I haven't taken any experimental cancer drugs or antibody therapies in the last 2 weeks.I am older than 18 years.I have low blood counts, a large spleen, growing cancer masses, or quickly increasing cancer cells.I do not have any severe illnesses that my doctor thinks could make participating unsafe for me.I am on steroids without a dose increase for at least 1 week.I have HCL/HCLv and can't use or haven't responded to specific treatments.I am currently taking warfarin.My cancer is confirmed as HCL or HCLv by specific tests.I haven't had CAR therapy in the last 30 days or have no lasting CAR T-cells.I had a stem cell transplant over 100 days ago, have no active GVHD, and haven't taken immunosuppressants for 30 days.I have a brain condition but it meets the study's specific requirements.My diagnosis of hairy cell leukemia is confirmed by specific tests.My disease can be measured or seen through tests.I can care for myself but may not be able to do active work, except if my condition is due to HCL.My organs are functioning well and I've recovered from previous treatment side effects.I had another cancer but was treated successfully over two years ago and am now in remission, except for cervical carcinoma in situ.My cancer cells show high CD22 levels.I haven't had chemotherapy, immunotherapy, or radiation in the last 2 weeks.I have a growing mass or bone lesion larger than 2cm.I finished my radiation therapy at least 3 weeks ago, or it was less intense and I have measurable disease outside the treated area.My kidney function is within the required range.I have a brain condition but may still qualify for the trial.Over 80% of my cancer cells show CD22.My cancer can be measured or seen through tests.My organs are functioning well and I've recovered from previous treatment side effects.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental therapy: Dose Escalation
- Group 2: Experimental therapy: Dose Expansion
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.
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