Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies

Completed · Phase 1

Conditions studied: NHL, Large Cell Lymphoma, Follicular Lymphoma, ALL, B-All, B-precursor ALL, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, B-Non Hodgkin Lymphoma, B-NHL

In brief

Background: \- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells. Objective: \- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective. Eligibility: \- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy. Design: * Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests. * Participants may have eye and neurologic exams. * Participants will get a central venous catheter or a catheter in a large vein. * Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm. * The cells will be changed in a laboratory. * Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this. * All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone. * Participants will have many blood tests. They may repeat some screening exams. * Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams. * Participants will have follow-up for 15 years.

Key facts

Study ID

NCT02315612

Run by

National Cancer Institute (NCI)

People needed

134

Starts

2014-12-12

Expected to finish

2024-10-29

Last updated by the study team

2026-04-28

Who can join

Age: 3 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects meeting any of the following criteria are not eligible for participation in the study:
• Subjects with radiologically-detected active CNS lymphoma, leptomeningeal CNS disease or isolated CNS disease which are eligible for definitive CNS directed radiationtherapy will be excluded.
• Hyperleukocytosis (greater than or equal to 50,000 blasts/ L) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
• Pregnant or breast-feeding females
• Recent prior therapy
• Subjects will be excluded related to the following prior therapy criteria:
• Systemic chemotherapy, anti-neoplastic investigational agents, or antibody based therapies <= 2 weeks (6 weeks for clofarabine or nitrosoureas) prior to apheresis with the following exception:
• -No time restriction with prior intrathecal chemotherapy, steroid therapy, hydroxyurea or ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for patients with Ph+ ALL) provided there is recovery from any acute toxic effects.
• Radiation therapy <= 3 weeks prior to apheresis with the following exception:
• -No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the subject has measurable/evaluable disease outside the radiation window.
• History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
• Less than 100 days post-transplant
• Evidence of active graft-versus-host disease (GVHD)
• Taking immunosuppressive agents within 30 days prior to apheresis.
• Less than 6 weeks post donor lymphocyte infusion (DLI)
• History of prior CAR therapy or other adoptive cell therapies prior to apheresis that meet the following criteria:
• Less than 30 days post-infusion
• Circulating CAR T cells (or genetically modified cells) >=5% by flow cytometry in peripheral blood
• HIV/HBV/HCV Infection:
• Seropositive for HIV antibody. (Patients with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy in the future should study results indicate effectiveness.)
• Positive for Hepatitis B surface antigen (HbsAG)
• Evidence of active HCV (evidenced by detectable HCV RNA)
• Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject;
• Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission;
• History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells (i.e. gentamicin)

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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