Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients

Launched by HRAIN BIOTECHNOLOGY CO., LTD. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with Central Nervous System (CNS) Lymphoma, specifically those who have not responded to previous therapies or whose cancer has come back. The treatment involves using specially modified T cells that target specific proteins on cancer cells. The goal of this trial is to see how safe the treatment is, how well it works, and how the body handles it.

To participate in the trial, patients must be between 18 and 70 years old and have a type of B cell cancer that shows certain markers (CD19 or CD22) in their body. They should also be able to expect to live for at least 12 weeks and have a good level of overall health. Participants will undergo procedures to collect their blood cells, which will then be treated and injected back into their bodies. This trial is currently looking for volunteers, and it’s important for anyone considering joining to discuss it with their doctor to understand all the details and any potential risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:
• • B cell malignancies patients with CD19 or CD22 positive, or CD19 and CD22 positive，include B cell acute lymphoblastic leukemia relapsed with central nervous system invasion and refractory/relapsed B cell lymphoma of central nervous system;
• • 18 to 70 years old (including cut-off value), Male and female;
• • Expected survival \> 12 weeks;
• • ECOG score 0-2;
• • Definitive diagnosed as central nervous system of B cell malignancies by Cerebrospinal fluid and/or MRI, PET/CT or other imaging examinations;
• • The venous access required for collection can be established and leukapheresis can be carried according to the judgement of investigators;
• * Liver, kidney and cardiopulmonary functions meet the following requirements:
• • 1. The detection value of Creatinine within the normal range;
• • 2. Left ventricular ejection fraction \> 50%;
• • 3. Baseline oxygen saturation \> 92%;
• • 4. Total bilirubin ≤ 2×ULN;
• • 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
• • Able to understand and sign the Informed Consent Document.
• Exclusion Criteria:Any one of the following conditions cannot be selected as a subject:
• • Malignant tumors other than B cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection;
• • Subjects with positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection higher than or equal to the lower limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis detection positive;
• • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
• • Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
• • Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
• • Received CAR-T treatment or other gene therapies before enrollment;
• • Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell infusion;
• • The investigators consider other conditions unsuitable for enrollment.

Trial Officials