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NCT Number: NCT07127289

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous hematopoietic stem cell infusion

Biological

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

Primary outcomes

  1. Changes in Neutrophil Counts After Autologous Stem Cell Infusion

    Time frame: up to 6 months after infusion

    Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.

  2. Changes in Platelet Counts After Autologous Stem Cell Infusion

    Time frame: up to 6 months after infusion

    Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.

  3. Changes in Hemoglobin Levels After Autologous Stem Cell Infusion

    Time frame: up to 6 months after infusion

    Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.

  4. Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion

    Time frame: up to 6 months after infusion

    Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.

Secondary outcomes

  1. Incidence of Infections After Autologous Stem Cell Infusion

    Time frame: up to 6 months after infusion

    Evaluate the frequency and types of infections following stem cell infusion, including bacterial, viral, and fungal infections.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang An, PhD&MD

CONTACT

[email protected]

86-022-23909171

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Acronym: ICAHT-001

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.