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

NCT ID: NCT07127289

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-08-31

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.

Conditions

Prolonged Cytopenia Following CAR-T Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous hematopoietic stem cell infusion

Group Type: EXPERIMENTAL

Autologous hematopoietic stem cell infusion

Intervention Type: BIOLOGICAL

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

Interventions

Autologous hematopoietic stem cell infusion

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gang An, PhD&MD

Role: CONTACT

angang@ihcams.ac.cn

86-022-23909171

Facility Contacts

Gang An

Role: primary

angang@ihcams.ac.cn

86-022-23909171

Other Identifiers

IIT2025001

Identifier Type: -

Identifier Source: org_study_id