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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Ability to understand and willingness to sign a written informed consent form (ICF).
2. Age ≥ 18 years.
3. Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
4. 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.
5. 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.
6. Availability of ≥ 1 × 10⁶/kg autologous hematopoietic stem cells in reserve.
Exclusion Criteria:
1. Known intolerance, hypersensitivity, or contraindication to autologous hematopoietic stem cell infusion.
2. Active hepatitis B or hepatitis C virus infection.
3. Known HIV infection.
4. Life expectancy \<6 months.
5. Woman who are pregnant or breastfeeding.
6. Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
7. Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
Primary outcome measure(s)
Changes in Neutrophil Counts After Autologous Stem Cell Infusion — up to 6 months after infusion Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.
Changes in Platelet Counts After Autologous Stem Cell Infusion — up to 6 months after infusion Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.
Changes in Hemoglobin Levels After Autologous Stem Cell Infusion — up to 6 months after infusion Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.
Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion — up to 6 months after infusion Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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