CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies (NCT04088864) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
United States10 participantsStarted 2020-01-10
Plain-language summary
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).
Who can participate
Age range1 Year ā 30 Years
SexALL
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Inclusion criteria
ā. Disease Status Disease Status of ALL
ā. Measureable Disease
ā. CD22 expression
ā. 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.
ā. Prior Therapy Wash-out
ā. Prior CAR Therapy Subjects who have undergone prior CAR therapy will be eligible if at least 30 days has elapsed prior to apheresis.
ā. Toxicities from Prior Therapy Toxicities due to prior therapy must be stable (except for clinically non significant toxicities such as alopecia)
ā. Age greater than or equal to 1 year and ā¤ 30 years of age at time of enrollment. First 3 subjects treated at the dose level must be at least 16 years old (enrolled on either pediatric or adult protocol).
Exclusion criteria
ā. Recurrent or refractory ALL limited to isolated testicular disease.
ā. Hyperleukocytosis (ā„ 50,000 blasts/Ī¼L) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
What they're measuring
1
Rate of successful manufacture of CD22 CAR T cells
Timeframe: 7-11 days after apheresis
2
Safe dose of CD22-CAR T cells in subjects with R/R B-cell malignancies
. 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
ā. 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.
ā. 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.
ā. 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.
ā. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
ā. Any medical condition that in the judgement of the sponsor investigator is likely to interfere with assessment of safety or efficacy of study treatment