A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
- Registration Number
- NCT04571138
- Lead Sponsor
- Seattle Children's Hospital
- Brief Summary
Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCRI-CAR22v2 SCRI-CAR22v2 Patients will receive SCRI-CAR22v2 in either Phase I or Phase II
- Primary Outcome Measures
Name Time Method The adverse events associated with CAR T cell product infusions will be assessed 28 days post-infusion The type, frequency, severity, and duration of adverse events will be summarized
The ability to successfully manufacture SCRI-CAR22v2 28 days We will measure the number of successfully manufactured SCRI-CAR22v2 products
The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed 28 days post-infusion The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's National Hospital
🇺🇸Washington, District of Columbia, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States