Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL

Launched by SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES · Oct 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called anti-CD19 CAR-NK cell therapy for patients with relapsed or resistant acute lymphocytic leukemia (B-ALL), a type of blood cancer. The goal of the trial is to see how safe this therapy is and to find out the highest dose that can be given without causing serious side effects. CAR-NK cell therapy works by using specially modified immune cells to target and attack cancer cells. This new approach may have advantages over other treatments, like CAR-T therapy, by causing fewer reactions in the immune system and being easier to produce.

To participate in this trial, patients must be at least 3 years old, have been diagnosed with B-ALL that expresses the CD19 protein, and have a life expectancy of more than 12 weeks. Participants will need to meet certain health criteria, including having adequate blood cell counts and organ function. Women who can become pregnant will need to have a negative pregnancy test and use contraception during the study. The trial is not yet recruiting participants, but it aims to carefully monitor how patients respond to the treatment and gather important safety information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligible diseases: Acute lymphocytic leukemia (ALL CD19+). Patients 3 years of age or older, and must have a life expectancy \> 12 weeks. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
• • Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR NK cells.
• • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
• • Ability to give informed consent.
• Exclusion Criteria:
• • Pregnant or nursing women may not participate. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
• • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
• • History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
• • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
• • The existence of unstable or active ulcers or gastrointestinal bleeding. Patients need anticoagulant therapy (such as warfarin or heparin). Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
• • Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.