RecruitingPhase 1

Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant

United States27 participantsStarted 2022-05-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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* INCLUSION CRITERIA * Histologically confirmed diagnosis of HCL or HCLv according to morphological and immunophenotypic criteria of WHO classification \[WHO, 2008 revised 2016\] of lymphoid neoplasm. * Participants should have any of the following indications for therapy: * ANC \<1/nL, * Hemoglobin \<10g/dL, * Platelets\<100/nL, * Symptomatic splenomegaly, * HCL mass with short axis \> 2 cm outside or \>0.5 cm inside the CNS, * HCL/HCLv count \>5/nL in blood or \>25/mm\^3 in CSF, * HCL/HCLv count doubling time \<6 months and increasing lytic or blastic bone lesions Participants who have eligible blood counts within 4 weeks from the initiation of study will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment. * HCL/HCLv, after prior treatment with, ineligible for, refusal of, or inability to obtain 1)rituximab given concurrently with or sequentially after purine analog, 2) moxetumomab pasudotox-tdft, and 3) BRAF-inhibition. * CD22 expression must be detected on greater than 80% of malignant cells by flow cytometry. * Participants must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease (MRD) detected by flow cytometry or immunohistochemistry. * Age \>=18 years * ECOG performance \<=2 (Karnofsky \>=60%, see Appendix A), participants are exempt from this criterion if poor performance sta…

What they're measuring

safety and feasibility

Timeframe: end of treatment

antitumor effect

Timeframe: every year for 15 years

Trial details

NCT IDNCT04815356

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2036-12-01

Contact for this trial

Olena S Sierra Ortiz

(240) 858-3185 olena.sierraortiz@nih.gov