Clonal Hematopoiesis does not influence manufacturing of Chimeric Antigen Receptor (CAR) T-Cells - Report - MDSpire

Clonal Hematopoiesis does not influence manufacturing of Chimeric Antigen Receptor (CAR) T-Cells

  • By

  • Simon M. Krauß

  • Konstantin Weibl

  • Enrica Bach

  • Mandy Brückner

  • Anne Weigert

  • Theresa Tumewu

  • Elena Ruschpler

  • Gunhild Vogtmann

  • Sandra Hoffmann

  • Olaf Penack

  • Martin Janz

  • Raymund Buhmann

  • Reinhard Henschler

  • Lars Bullinger

  • Ulrich Keller

  • Sebastian Schwind

  • Maximilian Merz

  • Madlen Jentzsch

  • Georg-Nikolaus Franke

  • Marco Herling

  • Uwe Platzbecker

  • Klaus H. Metzeler

  • Vladan Vučinić

  • June 3, 2026

  • 0 min

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Clinical Report: Clonal Hematopoiesis Does Not Affect CAR T-Cell Production

Overview

This study investigates the impact of clonal hematopoiesis (CH) on the manufacturing success of chimeric antigen receptor (CAR) T-cells in patients with large B-cell lymphoma.

Background

Chimeric antigen receptor (CAR) T-cell therapy has emerged as a potent treatment for various hematologic malignancies, including large B-cell lymphoma. Understanding factors that may affect the manufacturing process of CAR T-cells is crucial, especially in heavily pretreated patient populations where clonal hematopoiesis may be prevalent. This study aims to clarify whether CH influences the success of CAR T-cell production.

Data Highlights

ParameterValue
Patients Analyzed49
Successful Collections34 (70%)
Terminations7 (14%)
Out of Specification Products8 (16%)
CH Prevalence23/49 (47%)
Median Age61 years

Key Findings

  • Clonal hematopoiesis (CH) mutations were detected in 23 out of 49 patients (47%).
  • The median variant allele frequency (VAF) of CH mutations was 1.6%.
  • Manufacturing of CAR T-cells was successful in 34 collections (70%).
  • CH prevalence was similar across successful collections, terminations, and out of specification products.
  • No association was found between CH status and proliferation-related manufacturing failure.

Clinical Implications

The findings suggest that the presence of clonal hematopoiesis does not adversely affect the manufacturing success of CAR T-cells. This information may help clinicians in understanding the implications of CH in treatment planning for patients undergoing CAR T-cell therapy.

Conclusion

This study concludes that clonal hematopoiesis does not impact the production of CAR T-cells, indicating that CH should not be a deterrent in the manufacturing process for CAR T-cell therapy.

Related Resources & Content

  1. Author(s)/Org, Source, Year -- Title
  2. Jadlowsky et al, ASCO Post, 2025 -- CAR T-Cell Therapy Not Linked to Secondary Cancers
  3. Jae H. Park, ASCO Post, 2025 -- Reducing the Barriers to Receiving CAR T-Cell Therapy for Patients With Hematologic Malignancies
  4. Blood Cancer Journal — Switching CAR T cells on and off: a novel modular platform for retargeting of T cells to AML blasts
  5. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases
  6. CARVYKTI | FDA
  7. ABECMA | FDA
  8. FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.) | FDA
  9. Diffuse Large B-cell Lymphoma (DLBCL) | ESMO
  10. Comparative efficacy and safety of CAR T-cell therapy versus standard of care for relapsed/refractory diffuse large B-cell lymphoma: A meta-analysis. | Journal of Clinical Oncology
  11. April 5, 2024 Clinical Review and Evaluation - CARVYKTI
  12. FDA Approval Summary: Idecabtagene Vicleucel for the Treatment of Triple-Class Exposed, Relapsed or Refractory Multiple Myeloma - PMC
  13. Symposium Proceedings of the international symposium ACUTE LEUKEMIAS XIX (ISALXIX), Munich March 16–19, 2025 | Annals of Hematology | Springer Nature Link
  14. Pre-existing clonal hematopoiesis in CAR-T recipients is not associated with increased immunotoxicity and inflammatory serum signatures - ScienceDirect
  15. Impact of clonal hematopoiesis on clinical outcomes to BCMA CAR-T in multiple myeloma - PubMed
  16. Clonal evolution and the risk of secondary myeloid neoplasia following chimeric antigen receptor T-cell therapy | Haematologica

Original Source(s)

Clonal Hematopoiesis does not influence manufacturing of Chimeric Antigen Receptor (CAR) T-Cells

  • by Simon M. Krauß, Konstantin Weibl, Enrica Bach, Mandy Brückner, Anne Weigert, Theresa Tumewu, Elena Ruschpler, Gunhild Vogtmann, Sandra Hoffmann, Olaf Penack, Martin Janz, Raymund Buhmann, Reinhard Henschler, Lars Bullinger, Ulrich Keller, Sebastian Schwind, Maximilian Merz, Madlen Jentzsch, Georg-Nikolaus Franke, Marco Herling, Uwe Platzbecker, Klaus H. Metzeler, Vladan Vučinić

  • June 3, 2026

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