OncoMatch/Clinical Trials/NCT04815356
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant
Is NCT04815356 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD22CART cell infusion for hairy cell leukemia.
Treatment: CD22CART cell infusion — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hairy Cell Leukemia
Biomarker criteria
Required: CD22 expression >80% (>80% of malignant cells by flow cytometry)
CD22 expression must be detected on greater than 80% of malignant cells by flow cytometry.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: rituximab given concurrently with or sequentially after purine analog
after prior treatment with, ineligible for, refusal of, or inability to obtain 1)rituximab given concurrently with or sequentially after purine analog
Must have received: moxetumomab pasudotox-tdft (moxetumomab pasudotox-tdft)
after prior treatment with, ineligible for, refusal of, or inability to obtain ... 2) moxetumomab pasudotox-tdft
Must have received: BRAF inhibitor
after prior treatment with, ineligible for, refusal of, or inability to obtain ... 3) BRAF-inhibition
Cannot have received: CAR-T cell therapy
Exception: allowed if >30 days prior to apheresis and no evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of <5% by flow cytometry)
Prior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of >= 5% by flow cytometry)
Lab requirements
Blood counts
Serum albumin > 2 g/dL; PT/INR < 2.5x ULN (if on warfarin, PT/INR < 3.5x ULN; if on any other anticoagulation, PT < 2.5x ULN); Fibrinogen >= 0.5x lower limit of normal
Kidney function
Serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal calculated using eGFR or measured
Liver function
Total bilirubin <= 3 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin > 5); ALT and AST <= 3x ULN; Alkaline phosphatase < 2.5 ULN
Participants must have adequate organ function as defined below: ... Total bilirubin <= 3 ULN, unless consistent with Gilbert's ... ALT and AST <= 3x ULN ... Alkaline phosphatase < 2.5 ULN ... Serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/min/1.73 m^2 ... Serum albumin > 2 g/dL ... PT/INR < 2.5x ULN (if on warfarin, PT/INR < 3.5x ULN; if on any other anticoagulation, PT < 2.5x ULN) ... Fibrinogen >= 0.5x lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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