A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

Launched by SEATTLE CHILDREN'S HOSPITAL · Sep 25, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for children and young adults with leukemia or lymphoma that has not responded to other treatments, including chemotherapy. The study is using a special approach called CAR T cell therapy, which involves taking T cells (a type of immune cell) from the patient and genetically modifying them to better recognize and attack cancer cells. Specifically, the modified T cells will target a protein called CD22 that is found on the surface of these cancer cells. The first part of the trial will focus on checking the safety of this treatment and finding the right dose, while the second part will look at how effective it is.

To be eligible for this trial, participants must be between 30 years old or younger and have a form of leukemia or lymphoma that is resistant to current treatments. They should also be well enough to undergo a procedure to collect their T cells (called apheresis) and have recovered from any side effects of previous treatments. Potential participants need to sign a consent form, and if someone is able to have children, they must agree to use effective birth control during the study. Participants will be monitored closely throughout the trial, and they can expect to learn more about their condition and the potential benefits and risks of this innovative therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
• • Evidence of refractory or recurrent CD22+ leukemia or lymphoma
• • Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
• • Life expectancy ≥ 8 weeks
• • Lansky or Karnofsky, as applicable, score ≥ 50
• • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
• • ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
• • ≥ 7 days post last corticosteroid therapy
• • ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
• • ≥ 1 day post hydroxyurea
• • 30 days post most recent CAR T cell infusion
• • Adequate organ function
• • Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
• • Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
• • Subject and/or legally authorized representative has signed the informed consent form for this study
• Exclusion Criteria:
• • Presence of active malignancy other than disease under study
• • History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
• • CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
• • Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
• • For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
• • Presence of active severe infection,
• • Presence of primary immunodeficiency syndrome
• • Subject has received prior virotherapy
• • Pregnant or breastfeeding
• • Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered
• • Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol