Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous hematopoietic stem cell infusion.
- Who it may be relevant to
- Registry conditions: Prolonged Cytopenia Following CAR-T Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-Arm, Single-Center Study of Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
Overview
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.
Interventions
- Biological Autologous hematopoietic stem cell infusion
Autologous hematopoietic stem cell infusion (0.5-3.0×10\^6/kg)
Primary outcome measures
- Changes in Neutrophil Counts After Autologous Stem Cell Infusion [Time frame: up to 6 months after infusion]
- Changes in Platelet Counts After Autologous Stem Cell Infusion [Time frame: up to 6 months after infusion]
- Changes in Hemoglobin Levels After Autologous Stem Cell Infusion [Time frame: up to 6 months after infusion]
- Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion [Time frame: up to 6 months after infusion]
Secondary outcome measures (1)
- Incidence of Infections After Autologous Stem Cell Infusion [Time frame: up to 6 months after infusion]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07127289 · IIT2025001