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CD22 CAR T Cell Therapy for Hairy Cell Leukemia
Study Summary
This trial is testing whether it is safe to give anti-CD22 CAR T cells to people with hairy cell leukemia (HCL).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Experimental therapy: Dose Escalation
- Group 2: Experimental therapy: Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the tangible benefits that participating in this clinical trial might offer patients?
"The primary objectives of this long-term study are to assess the safety and feasibility of the treatment over the course of 15 years. Additionally, researchers will monitor for progression-free survival, event-free survival, and overall survival."
What is the total number of people who have signed up to participate in this research project?
"That is correct. The listing on clinicaltrials.gov indicates that this study, which was first made public on May 23rd, is recruiting patients. The research is only looking for 23 individuals from a single site."
What are some possible risks associated with CD22 CAR T-cell infusion?
"With CD22 CAR T-cell infusion, we are still in the early stages of research. This being a Phase 1 trial, there is limited data supporting both safety and efficacy, so we gave it a score of 1."
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