A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SCRI-CAR22v2 Patients will receive SCRI-CAR22v2 in either Phase I or Phase II |
Biological: SCRI-CAR22v2
Single infusion of SCRI-CAR22v2
|
Outcome Measures
Primary Outcome Measures
- he 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
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Evidence of refractory or recurrent CD22+ leukemia or lymphoma
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Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
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Life expectancy ≥ 8 weeks
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Lansky or Karnofsky, as applicable, score ≥ 50
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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
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≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
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≥ 7 days post last corticosteroid therapy
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≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
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≥ 1 day post hydroxyurea
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30 days post most recent CAR T cell infusion
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Adequate organ function
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Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
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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
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Subject and/or legally authorized representative has signed the informed consent form for this study
Exclusion Criteria:
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Presence of active malignancy other than disease under study
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History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
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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
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Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
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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
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Presence of active severe infection,
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Presence of primary immunodeficiency syndrome
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Subject has received prior virotherapy
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Pregnant or breastfeeding
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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
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Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 2 | Children's National Hospital | Washington | District of Columbia | United States | 20010 |
| 3 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 4 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
| 5 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Seattle Children's Hospital
Investigators
- Study Chair: Corinne Summers, MD, Seattle Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLAT-07