Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy (ICAHT-001)

A Prospective, Single-Arm, Single-Center Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Prolonged Cytopenia Following CAR-T Therapy
• Intervention / Treatment: Biological: Autologous hematopoietic stem cell infusion

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gang An, PhD&MD; Phone Number: 86-022-23909171; Email: angang@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
      • Contact: Gang An; Phone Number: 86-022-23909171; Email: angang@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous hematopoietic stem cell infusion	Biological: Autologous hematopoietic stem cell infusion; Autologous hematopoietic stem cell infusion (0.5-3.0×10^6/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Neutrophil Counts After Autologous Stem Cell Infusion	Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.	up to 6 months after infusion
Changes in Platelet Counts After Autologous Stem Cell Infusion	Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.	up to 6 months after infusion
Changes in Hemoglobin Levels After Autologous Stem Cell Infusion	Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.	up to 6 months after infusion
Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion	Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.	up to 6 months after infusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CAR-T; Stem cell; prolonged cytopenia
• Additional Relevant MeSH Terms: Leukocyte Disorders; Hematologic Diseases; Blood Platelet Disorders; Cytopenia; Thrombocytopenia; Anemia; Leukopenia
• Other Study ID Numbers: IIT2025001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No