Actively Recruiting
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant
Led by National Cancer Institute (NCI) · Updated on 2026-05-05
27
Participants Needed
1
Research Sites
758 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of hairy cell leukemia (HCL) or HCL variant (HCLv) according to WHO classification
- Indications for therapy including low neutrophil count (ANC <1/nL), low hemoglobin (<10 g/dL), low platelets (<100/nL), symptomatic enlarged spleen, HCL mass >2 cm outside or >0.5 cm inside the central nervous system, high HCL/HCLv counts in blood or cerebrospinal fluid, or rapid disease progression with bone lesions
- Prior treatment with or ineligible for rituximab, moxetumomab pasudotox-tdft, and BRAF inhibitors
- CD22 expression on more than 80% of malignant cells by flow cytometry
- Measurable or evaluable disease at enrollment
- Age 18 years or older
- ECOG performance status 0 to 2 (or Karnofsky score >=60%), except if poor status is due to HCL
- Adequate organ function with specific lab value limits for bilirubin, liver enzymes, alkaline phosphatase, creatinine, and albumin
- Prothrombin time/INR limits depending on anticoagulation use
- Fibrinogen level at least half the lower limit of normal
- Participants with CNS disease allowed with exceptions
- Participants post-allogeneic stem cell transplant eligible if at least 100 days post-transplant with no active graft-versus-host disease and off immunosuppressants for 30 days
- Women of childbearing potential and men must agree to use effective contraception for specified periods
- Breastfeeding participants must agree to stop breastfeeding during treatment and follow-up
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnancy
- Chemotherapy, immunotherapy, or radiation therapy within 2 weeks prior to leukapheresis, with exceptions for stable steroid use and certain radiation timing
- Current or recent use of other investigational anti-cancer agents or antibody therapies within 2 weeks prior to leukapheresis
- Use of warfarin anticoagulation
- Prior CAR T-cell therapy within 30 days or evidence of persistent CAR T cells
- Positive for HIV antibodies
- Positive for hepatitis C virus or hepatitis B surface antigen, unless converted to negative
- Uncontrolled or symptomatic illnesses such as infections, heart failure, unstable angina, arrhythmias, asthma, COPD, psychiatric illness, or social situations limiting study compliance
- History of severe allergic reaction to components used in the study or cell manufacturing such as gentamicin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
O
Olena S Sierra Ortiz
CONTACT
R
Robert J Kreitman, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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