Actively Recruiting
Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma
Led by Anhui Provincial Hospital · Updated on 2025-05-29
18
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, single-site, dose-escalation study in up to 18 participants with Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
CONDITIONS
Official Title
Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian provides informed consent
- Age over 3 years at time of consent
- Confirmed diagnosis of acute B-cell leukemia, B-cell lymphoma, or multiple myeloma meeting specific subtypes and relapse or refractory status
- At least one measurable lesion for B-cell lymphoma patients
- Bone marrow primitive and naive lymphocytes proportion of 5% or more in B-ALL patients
- CD19 expression confirmed in tumor cells by flow cytometry or immunohistochemistry
- Adequate vital organ function including liver, kidney, heart, and lung
- ECOG performance status of 0 to 2
- Expected survival of more than 3 months as judged by the investigator
- Use of reliable contraception for 2 years after consent if of childbearing potential
You will not qualify if you...
- Central nervous system disease or pathological changes within 6 months prior to screening
- Isolated extramedullary recurrence in B-ALL patients
- Malignancies other than specified diagnoses
- Anti-tumor therapies within 14 days or less than 5 half-lives before cell collection
- Vaccination or B-cell targeted therapy within 4 weeks prior to screening
- Systemic autoimmune disease or immunodeficiency
- Grade 2 to 4 acute or moderate to severe chronic graft-versus-host disease within 4 weeks prior to screening
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Severe allergies to study drugs or their components
- Active infections such as hepatitis B, HCV, HIV, or syphilis
- Active infection requiring intravenous antibiotics or hospitalization
- Pregnant or lactating women
- Other conditions deemed unsuitable by investigators for safety or efficacy assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Actively Recruiting
Research Team
B
bing xing wang, M.D
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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