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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07127289

Acronym

ICAHT-001

Enrollment

Registered

2025-08-17

Start date

2025-08-31

Completion date

2028-08-31

Last updated

2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Cytopenia Following CAR-T Therapy

Keywords

Stem cell, CAR-T, prolonged cytopenia

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.

Interventions

BIOLOGICALAutologous hematopoietic stem cell infusion

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactGang An, PhD&MD

angang@ihcams.ac.cn86-022-23909171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026