Clinical trial · Interventional
Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-03: A Pilot Feasibility and Safety Study of CD19t T-Antigen Presenting Cells (T-APCs) Following CAR T Cell Immunotherapy for CD19+ Leukemia
- 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 CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD 19+ Acute Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Participants will receive CD19-targeting CAR T cells. Participants who have a total CD19 antigen load in bone marrow of \<15% will be assigned to Cohort A, to receive up to 6 T-APC treatments.
- interventionNames
- Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Participants will receive CD19-targeting CAR T cells. Participants for whom laboratory testing on Study Day 14 indicates they are at risk for early loss of CAR T cells will be assigned to Cohort B to receive up to 6 T-APC treatments. If laboratory testing prior to planned T-APC treatment indicates loss of CAR-T cells, participants may move to Cohort C.
- interventionNames
- Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of recurrent or refractory CD19+ leukemia * Adequate performance status * Able to tolerate apheresis, including placement of temporary apheresis line if required * Adequate renal, liver, cardiac, and respiratory function * Adequate absolute lymphocyte count * HIV negative; Hepatitis B and C negative within 3 months prior to enrollment. Exclusion Criteria: * Evidence of active clinically significant CNS dysfunction * Evidence of active malignancy other than CD19+ malignancy * Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment
References
Publications (1)
- DERIVEDAnnesley C, Seidel K, Wu Q, Summers C, Wayne AS, Pulsipher MA, Agrawal AK, Brown CT, Mgebroff S, Lindgren C, Rawlings-Rhea S, Huang W, Wilson AL, Jensen MC, Park JR, Gardner RA. Outcomes of PLAT-02 and PLAT-03: evaluating CD19 CAR T-cell therapy and CD19-expressing T-APC support in pediatric B-ALL. Blood. 2025 Aug 14;146(7):789-801. doi: 10.1182/blood.2025028359. PMID 40233328