Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
Recruiting now · Phase 2
Conditions studied: Prolonged Cytopenia Following CAR-T Therapy
In brief
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.
Key facts
- Study ID
- NCT07127289
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 20
- Starts
- 2025-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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