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NCT04815356 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant
A Phase 1 study of Hairy Cell Leukemia and Hairy Cell Leukemia Variant, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT04815356: Recruiting Phase 1 study of Hairy Cell Leukemia and Hairy Cell Leukemia Variant, sponsored by National Cancer Institute (NCI).
NCT04815356 is a Phase 1 study of Hairy Cell Leukemia and Hairy Cell Leukemia Variant that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04815356, a Phase 1 study of Hairy Cell Leukemia and Hairy Cell Leukemia Variant, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: CAR (Chimeric Antigen Receptor) T cell therapy is a type of cancer treatment in which a person s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells. Researchers want to see if this treatment can help people with hairy cell leukemia (HCL). Objective: To test whether it is safe to give anti-CD22 CAR T cells to people with HCL. Eligibility: Adults ages 18 and older with HCL (classic or variant type) who have already had, are unable to receive, or have refused other standard treatments for their cancer. Design: Participants will be screened with the following: Medical history Physical exam Blood and urine tests Biopsy sample Electrocardiogram Echocardiogram Lung function tests Imaging scans Some screening tests will be repeated during the study. Participants may need to have a catheter placed in a large vein. Participants will have magnetic resonance imaging of the brain. Participants will have a neurologic evaluation and fill out questionnaires. Participants will have leukapheresis. Blood will be removed from the participant. A machine will divide whole blood into red cells, plasma, and lymphocytes. The lymphocytes will be collected. The remaining blood will be returned to the participant. Participants will get infusions of chemotherapy drugs. Participants will get an infusion of the anti-CD22 CAR T cells. They will stay at the hospital for 14 days. Then they will have visits twice a week for 1 month. After treatment, participants will be followed closely for 6 months, and then less frequently for at least 5 years. Then they will have long-term follow-up for 15 years.
Primary Outcome
Fraction of participants at each dose level who experience a toxicity along with the grades and types of toxicity and which can successfully manufacture the targeted dose number
Conditions Studied
Interventions
- BIOLOGICAL CD22CART cell infusion
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-05-23 |
| Est. Completion | 2036-12-01 |
| Phase | Phase 1 |
What NCT04815356 shows while recruiting
NCT04815356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 71-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD22CART cell infusion is the first listed.
NCT04815356 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04815356 about?
NCT04815356 is a clinical study titled "Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant". Background: CAR (Chimeric Antigen Receptor) T cell therapy is a type of cancer treatment in which a person s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells. Researchers want to see if this treatment can help people with hairy cell leukemia (HCL). O...
What is the current status of trial NCT04815356?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-05-23. Estimated completion is 2036-12-01.
What conditions does trial NCT04815356 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia, Hairy Cell Leukemia Variant.
What interventions are being tested in trial NCT04815356?
The interventions under investigation include: CD22CART cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT04815356?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04815356 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04815356's enrollment target sits among peer trials
27 14th of 15 higher than 2 of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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