The Bone Marrow Transplantation & Cellular Therapy Department conducts CAR T-cell clinical trials for children and young adults with relapsed or refractive leukemia. These studies use chimeric antigen receptor (CAR) products developed and produced at the Children’s GMP, LLC, which is located on the St. Jude campus.
St. Jude Clinical Trials
3CAR: B7-H3-specific CAR T-cell Therapy for Children and Young Adults with Solid Tumors
Diseases Treated:
Eligibility:
Inclusion criteria include:
- 21 years old or younger
- Relapsed or refractory B7-H3-positive solid tumor
CATCHAML: CAR T-Cell Therapy for Acute Myelogenous Leukemia (AML)
Diseases Treated:
Eligibility:
- 21 years old or younger
- Relapsed/refractory CD123+ AML, B-ALL, T-ALL or blastic plasmacytoid dendritic cell neoplasm
- Has a suitable bone marrow transplant donor for allogeneic bone marrow transplant
DIRECT70: CAR T–Cell Therapy for Children with Blood Malignancies
Diseases Treated:
Eligibility:
- Up to 21 years old
- CD70+ acute myeloid leukemia, acute lymphoblastic leukemia (B-ALL, T-ALL), lymphoma, or myelodysplastic syndrome
- If prior allogeneic hematopoietic cell transplant, no graft vs. host disease
- Has an identified hematopoietic cell transplantation donor
- Has adequate organ function
Loc3CAR: CAR T-Cell Therapy for Pediatric CNS Tumors
Diseases Treated:
Eligibility:
- Up to 21 years old
- Either B7-H3–positive relapsed or refractory non-brainstem primary CNS tumor or brainstem high-grade neoplasm
MEMCAR19: Allogeneic CAR T-Cell Therapy for Relapsed/Refractory CD19-Positive Leukemia
Diseases Treated:
Eligibility:
Donor eligibility includes:
- At least 18 years old
- At least single haplotype matched family member
- HIV negative
- Not pregnant or breastfeeding
- Completed the process of donor eligibility determination as defined in the study
Recipient eligibility includes:
- 21 years old or younger*
- Diagnosed with relapsed and/or refractory CD19-positive leukemia (as defined in the study)
- Cohort A only – Relapsed and/or refractory CD19-positive leukemia AND previously received a hematopoietic cell transplant from the selected CAR-T donor
- Cohort B only: Can not receive autologous CD19-CAR T-cell therapy (as defined in the study)
- Detectable CD19+ leukemia in the bone marrow
- Adequate organ function (as defined in the study)
* Initial 3 participants must be at least 12 years old.
SJCAR19: CAR T-Cell Therapy for Children and Young Adults with Acute Lymphoblastic Leukemia
Diseases Treated:
Eligibility:
- Children and young adults up to 21 years old
- Refractory or relapsed CD19+ acute lymphoblastic leukemia (ALL)