Autologous stem cell infusion for prolonged low blood counts after CAR-T therapy

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

This will try giving adults who had CAR-T therapy for multiple myeloma an infusion of their own stem cells to treat prolonged low blood counts.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07127289 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, single-center phase 2 study enrolling about 20 adults with multiple myeloma who develop prolonged grade 3–4 cytopenias after CAR‑T cell therapy. Eligible participants must have stored autologous hematopoietic stem cells (≥1×10^6/kg) available for infusion. Enrolled patients will receive an infusion of their autologous stem cells and be followed for safety, blood count recovery, and related complications. The study primarily focuses on safety signals with secondary observations on time to hematologic recovery and need for transfusions or supportive care.

Who should consider this trial

Good fit: Adults (≥18) with multiple myeloma who received CAR‑T therapy, have persistent or new grade 3–4 cytopenias between 30 and 90 days after CAR‑T, and have ≥1×10^6/kg stored autologous stem cells are ideal candidates.

Not a fit: Patients with active hepatitis B or C, known HIV infection, intolerance to autologous stem cell infusion, or without sufficient stored stem cells are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, this could shorten severe cytopenias and lower the risk of infections, transfusion needs, and hospital stays.

How similar studies have performed: This approach is relatively novel with limited published evidence beyond small case series and reports, so safety and benefit are not yet well established.

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Gang An, PhD&MD

Conditions Prolonged Cytopenia Following CAR-T Therapy; Stem cell; CAR-T; prolonged cytopenia