NCT07127289 Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
| NCT ID | NCT07127289 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Prolonged Cytopenia Following CAR-T Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07127289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prolonged Cytopenia Following CAR-T Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07127289 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07127289 currently recruiting?
Yes, NCT07127289 is actively recruiting participants. Contact the research team at angang@ihcams.ac.cn for enrollment information.
Where is the NCT07127289 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07127289 clinical trial?
NCT07127289 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.