Actively Recruiting
An Early Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection Targeting CD19 and BCMA in Patients With Relapsed or Refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma
Led by Anhui Provincial Hospital · Updated on 2025-05-29
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment using Anti-BCMA and CD19 CAR-T cells for patients with relapsed or refractory Multiple Myeloma, Acute B-Cell Leukemia, and B-Cell Lymphoma. This open-label, single-site study aims to assess the safety and effectiveness of this treatment in up to 18 participants. The trial focuses on these blood cancers, exploring a therapy designed to target specific cancer markers. Before receiving the CAR-T cell infusion, patients will undergo chemotherapy with cyclophosphamide and fludarabine to prepare the body. On day 0, a single intravenous dose of Anti-BCMA and CD19 CAR-T cells will be given, with doses escalating from 1.0 to 5.0 x10^5 CAR-T cells per kilogram of body weight. This is an early exploratory clinical study without a placebo or comparator group. Participants will be monitored for up to 2 years after treatment. Researchers will track adverse events and study how the CAR-T cells persist, accumulate, and move within the body. They will also assess progression-free survival, overall survival, and objective response rates. Throughout the study, various tests and evaluations will occur to evaluate safety and treatment response.
CONDITIONS
Brief 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...
- The patient or guardian agrees to participate and signs informed consent
- Age over 3 years regardless of gender
- Confirmed diagnosis of acute B-cell leukemia, B-cell lymphoma, or multiple myeloma meeting specific subcategory criteria
- At least one measurable lesion for B-cell lymphoma patients as per imaging
- Bone marrow primitive and naive lymphocytes proportion 5% for B-ALL patients
- CD19 expression confirmed by flow cytometry or immunohistochemistry
- Adequate vital organ function and stable heart function
- ECOG performance score between 0 and 2
- Expected survival more than 3 months
- Agreement to use effective contraception for 2 years 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
- Presence of malignancies other than the specified blood cancers
- Anti-tumor therapies within 14 days 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 graft-versus-host disease or moderate to severe chronic GVHD within 4 weeks prior to screening
- Serious heart disease such as angina, myocardial infarction, heart failure, or arrhythmia
- Severe allergy to drugs used in the study
- Active hepatitis B, positive HCV antibody, HIV antibody, or syphilis
- Active infection requiring intravenous antibiotics or hospitalization
- Pregnant or lactating women
- Any other conditions that affect safety or study judgment as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day treatment with follow-up for up to 2 years
Participants receive lymphodepletion chemotherapy followed by a one-time intravenous infusion of anti-BCMA and CD19 CAR-T cells.
1 day infusion visit with multiple follow-up visits over 2 years
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
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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