Clinical trial · Interventional
CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-06: A Phase 1/2 Study of CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCRI-huCAR19v1 | Biological | — | UNRESOLVED |
| SCRI-huCAR19v2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCRI-huCAR19v2
- description
- Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II
- interventionNames
- Biological: SCRI-huCAR19v2
- type
- EXPERIMENTAL
- label
- SCRI-huCAR19v1 - [CLOSED]
- description
- Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed.
- interventionNames
- Biological: SCRI-huCAR19v1
Primary outcomes (2)
- measure
- The adverse events associated with CAR T cell product infusions will be assessed
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects age ≥ 1 and ≤ 30 years * First 2 enrolled subjects: age ≥ 18 and ≤ 30 years * Disease requirements: * Phase 1: Evidence of refractory or recurrent CD19+ leukemia or lymphoma following previous CAR T cell immunotherapy * Phase 2: Evidence of refractory or recurrent CD19+ leukemia or lymphoma * Able to tolerate apheresis, or has 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 * No prior virotherapy * ≥ 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 * 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 patient from undergoing treatment under this protocol
References
Publications (0)
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