CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies

Completed · Phase 1

Conditions studied: B Cell Lymphoma, Acute Lymphoblastic Leukemia, Pediatric, Lymphoma

In brief

The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and lymphoma). Another purpose of this study is to test the safety and cancer killing ability of a cell therapy against a new cancer target (CD22).

Key facts

Study ID

NCT04088864

Run by

Kara Lynn Davis

People needed

10

Starts

2020-01-10

Expected to finish

2022-01-13

Last updated by the study team

2026-05-26

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Disease Status Disease Status of ALL
• Must have chemotherapy refractory disease defined as progression or stable disease after two lines of therapies, or
• Relapsed disease after achieving CR.
• Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, fluorescence in situ hybridization (FISH), or next generation sequencing (NGS) require verification of MRD on two occasions at least 2 weeks apart.
• Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).
• Subjects with recurrence of isolated central nervous system CNS) relapse after achieving complete remission (CR).
• Disease Status of lymphoma
• Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:
• DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR primary mediastinal (thymic) large B cell lymphoma transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma to DLBCL will also be included
• Subjects with DLBCL must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody. Subjects with transformed Follicular lymphoma(FL), marginal zone B-cell lymphoma (MZL), or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) must have progressed, had SD, or recurred with transformed disease after initial treatment for DLBCL. Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.
• Measureable Disease
• Subjects with ALL must have evaluable or measurable disease.
• Subjects with lymphoma: Must have evaluable or measurable disease according to the revisedInternational Working. Group( IWG) Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
• CD22 expression
• Subjects with ALL: CD22 positive expression on malignant cells is required and must be detected by immunohistochemistry or by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject.
• CD22 expression must be demonstrated subsequent to any anti-CD22 targeted therapy (e.g. Moxetumomab pasudotox or inotuzumab ozogamicin) in subjects with ALL
• Subjects with lymphoma: must have archival tissue available for analysis of CD22 expression, or must be willing to undergo a biopsy of easily accessible disease.
• Prior Bone Marrow-Stem Cell Transplant Subjects who have undergone autologous stem cell transplant (SCT) with disease progression or relapse following SCT are eligible. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post transplant, they have no evidence of Graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days.
• Prior Therapy Wash-out
• At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half lives.
• Subjects with ALL may not have receive inotuzumab ozogamicin therapy within the past 4 months.
• Exceptions:
• There is no time restriction with regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such;
• Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis;
• Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6- mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week or 5 half-lives, whichever is shorter,prior to apheresis.

You may not qualify if…

• Recurrent or refractory ALL limited to isolated testicular disease.
• Hyperleukocytosis (≥ 50,000 blasts/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
• History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
• Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
• CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement hat in the judgment of the investigator may impair the ability to evaluate neurotoxicity.
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
• Any medical condition that in the judgement of the sponsor investigator is likely to interfere with assessment of safety or efficacy of study treatment
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Women of child bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• In the investigators judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation
• Has primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.

Where it is running

• Stanford Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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