A groundbreaking clinical trial is in development at St. Jude Children’s Research Hospital focusing on the use of CD45RA-depleted CD19-CAR T cells. This investigational approach pairs with TCRαβ+ T cell-depleted haploidentical hematopoietic cell transplantation (HCT). The aim is improving outcomes for pediatric patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL) and lymphoma.
The trial seeks to fill a critical gap in treatment alternatives for these high-risk patients, utilizing the CliniMACS System to prepare cellular therapeutic components for optimal safety and efficacy.
- What changed?
- What is the focus of the trial?
- Therapeutic components and device details
- Who will benefit?
- FAQs
- Conclusion
- Disclaimer
- Full announcement details
What changed?
This trial marks a significant interdisciplinary step in translational medicine. While standard therapies for relapsed pediatric ALL are limited, the initiation of a novel immune-mediated strategy targeting CD19+ malignancies provides new opportunities for clinical improvement. Not yet recruiting participants as of December 2025, this study signals a potential shift toward precision immunotherapy in hematologic pediatric cancers.
What is the focus of the trial?
The primary focus is optimizing the performance of CD19-CAR T cell technology after a haploidentical HCT procedure. By depleting CD45RA and TCRαβ+ T cells, researchers aim to minimize potential immunological complications, such as graft-versus-host disease, and enhance therapeutic efficiency against CD19-expressing leukemia and lymphoma cells. Early-stage safety assessments and eventual efficacy data will guide future treatment protocols.
Therapeutic components and device details
Key elements of this trial include the pharmacological agents and advanced device systems used:
- Drugs: Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide, Fludarabine, Thiotepa, Mesna, Melphalan, and Filgrastim are part of the conditioning regimen to prepare the immune system for transplantation.
- Medical Device: The CliniMACS System by Miltenyi Biotec plays a central role in depleting CD45RA and TCRαβ+ T cells. This process ensures well-prepared therapeutic cellular products, aligning with regulatory safety and performance standards.
This combination of drugs and devices reflects a concerted effort to maintain high levels of safety for pediatric populations while leveraging state-of-the-art immune-engineering advancements.
Who will benefit?
The trial is designed to benefit pediatric patients with relapsed and refractory CD19+ ALL or lymphoma, for whom conventional treatment options have proven inadequate. The advanced therapeutic strategies employed aim to offer better disease control and potential remission, addressing a critical unmet medical need in these high-risk cohorts. Healthcare providers, clinical teams, and regulatory professionals should monitor developments for practice-changing protocols.
FAQs
- 1. Who is conducting this trial? The trial is sponsored and conducted by St. Jude Children’s Research Hospital.
- 2. Why is the CliniMACS System significant? The CliniMACS System facilitates precision cell processing by depleting undesirable T cell subtypes, ensuring optimal immunotherapy performance.
- 3. When will recruitment begin? As of December 2025, recruitment has not yet started. Updates will follow as progress is made.
- 4. Who can participate? Pediatric patients diagnosed with relapsed or refractory CD19+ ALL or lymphoma are the primary target group for study participation.
Conclusion
This innovative clinical trial could redefine outcomes for relapsed pediatric ALL and lymphoma by combining advanced cellular therapies and a sophisticated medical device. The integration of immune engineering with precision medicine underscores the forward-thinking approach of St. Jude Children’s Research Hospital. Stakeholders in hematologic oncology should prepare for potential paradigm shifts in pediatric care pathways.
Disclaimer
For healthcare professionals only. This post is informational and not legal or clinical advice. Consult appropriate resources for detailed guidance.
Full announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07257419?term=medical+device