Genetically modified T cells for treating relapsed leukemia or lymphoma in young patients
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
This study is testing a new treatment using specially modified T cells to see if it can help young people with relapsed leukemia or lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | CAR T, chemotherapy, immunotherapy, chimeric antigen receptor |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT04571138 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients aged 30 years or younger who have relapsed or refractory leukemia or lymphoma. The study utilizes T cells harvested from the patients, which are genetically engineered to express a chimeric antigen receptor (CAR) that targets CD22, a protein found on the surface of cancer cells. The trial is divided into two phases: the first phase assesses the safety and appropriate dosing of these CAR T cells, while the second phase evaluates their effectiveness in treating the targeted conditions. Both previously treated and untreated patients may be eligible for participation.
Who should consider this trial
Good fit: Ideal candidates are male and female patients aged 30 years or younger with refractory or recurrent CD22+ leukemia or lymphoma.
Not a fit: Patients who do not have CD22+ leukemia or lymphoma or those with a life expectancy of less than 8 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for young patients with difficult-to-treat leukemia or lymphoma.
How similar studies have performed: Other studies utilizing CAR T cell therapy have shown promising results, indicating that this approach is gaining traction in the treatment of similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 4 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's National Hospital — Washington, District of Columbia, United States (Withdrawn)
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Corinne Summers, MD
- Email: CBDCIntake@seattlechildrens.org
- Phone: 206-987-2106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.