Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci w wieku 18 lat i starsi z potwierdzoną białaczką włochatokomórkową (klasyczną lub wariantem).
- •Choroba musi być nawrotowa lub oporna na inne metody leczenia, lub pacjent nie może przyjmować innych terapii.
- •Komórki białaczkowe muszą wykazywać obecność białka CD22 na swojej powierzchni (powyżej 80%).
- •Pacjent musi mieć aktywną chorobę, którą można zmierzyć lub ocenić.
- •Pacjent musi być w stanie ogólnym pozwalającym na udział w badaniu (ocena sprawności ECOG <=2).
✗ Disqualifies
- •Pacjent, który nie przeszedł lub jest niezdolny do otrzymania leczenia rytuksymabem, moxetumomab pasudotox-tdft lub inhibitorami BRAF.
- •Pacjent z nieprawidłowymi wynikami badań laboratoryjnych, które nie są związane z chorobą (HCL) lub nie ustąpiły po poprzednim leczeniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
National Institutes of Health Clinical Center
Bethesda, United States
Trial contact
Olena S Sierra Ortiz
Robert J Kreitman, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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