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

Not Applicable

Recruiting

• Conditions: Prolonged Cytopenia Following CAR-T Therapy
• Interventions: Biological: Autologous hematopoietic stem cell infusion

• Registration Number: NCT07127289
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Primary Completion: 2027-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous hematopoietic stem cell infusion	Autologous hematopoietic stem cell infusion	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Infections After Autologous Stem Cell Infusion	up to 6 months after infusion	Evaluate the frequency and types of infections following stem cell infusion, including bacterial, viral, and fungal infections.

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China