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RecruitingPhase 2NCT07127289

Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy

A Prospective, Single-Arm, Single-Center Study of Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Prolonged Cytopenia Following CAR-T Therapy

Summary

This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Ability to understand and willingness to sign a written informed consent form (ICF).
  • Age ≥ 18 years.
  • Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
  • Prior treatment with CAR-T cell therapy and currently in remission or, in the opinion of the investigator, with refractory/progressive disease not requiring salvage therapy.
  • Presence of grade 3-4 cytopenia (absolute neutrophil count < 1.0 × 10⁹/L, or platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L) either persisting or newly developed between day 30 and day 90 after CAR-T cell infusion; or deemed suitable for inclusion by the investigator based on clinical judgment.
  • Availability of ≥ 1 × 10⁶/kg autologous hematopoietic stem cells in reserve.

Exclusion Criteria7

  • Known intolerance, hypersensitivity, or contraindication to autologous hematopoietic stem cell infusion.
  • Active hepatitis B or hepatitis C virus infection.
  • Known HIV infection.
  • Life expectancy <6 months.
  • Woman who are pregnant or breastfeeding.
  • Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
  • Any other conditions that are not eligible for the trial in the judgement of the principal investigator.

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Interventions

BIOLOGICALAutologous hematopoietic stem cell infusion

Autologous hematopoietic stem cell infusion (0.5-3.0×10\^6/kg)

Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07127289