Actively Recruiting
Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-02-11
15
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.
CONDITIONS
Official Title
Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and able to sign informed consent
- Age 18 years or older
- Diagnosed with acute lymphoblastic leukemia, lymphoma, or myeloma and have severe cytopenia (neutrophil count ≤ 1x10⁹/L; platelet count ≤ 30x10⁹/L; or hemoglobin ≤ 70 g/L) 3 weeks after CAR-T infusion
- ECOG performance status score of 2 or less
- Estimated survival of 6 months or more
- Female patients of childbearing potential must have a negative pregnancy test and, along with male patients, agree to use effective contraception during the study and for 4 to 6 months after treatment ends
You will not qualify if you...
- Received other anti-tumor treatments affecting blood counts within 1 month before screening after CAR-T infusion
- Significant bone marrow infiltration by tumor cells during screening
- Infection with unstable hemodynamics, deep fungal infection, Pneumocystis jirovecii pneumonia, active tuberculosis, viremia, viral pneumonia, or other severe infections within 1 week before first dose
- Serum creatinine or blood urea nitrogen ≥ 1.5 times normal upper limit
- Liver enzymes (ALT or AST) ≥ 3 times upper limit of normal or total bilirubin ≥ 1.5 times upper limit
- Severe or uncontrolled diseases impacting study participation, including serious heart conditions, uncontrolled diabetes, refractory hypertension, or severe lung disease
- History of arteriovenous thrombosis or atherosclerosis
- Positive for HIV, syphilis antibodies, hepatitis B surface antigen, elevated hepatitis B DNA, or hepatitis C RNA
- History or current malignant solid tumor except certain cured skin or in situ carcinomas
- Within 6 months after allogeneic stem cell transplant or with certain graft-versus-host disease conditions
- Received live vaccine within 4 weeks before first dose or planning to receive one during study
- Pregnant or breastfeeding
- Mental disorders
- Participation in other drug or vaccine trials within 4 weeks or 5 half-lives before first dose
- Refusal to sign informed consent
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)
Tianjin, China, 300020
Actively Recruiting
Research Team
Z
Zhenzhen Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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