Actively Recruiting
CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-18
18
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
B
Beijing Gaobo Boren Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored
CONDITIONS
Official Title
CD5 CART for the Treatment of Relapsed and Refractory CD5 Hematological Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD5-positive B-cell lymphoma according to NCCN guidelines or CD5-positive T-cell lymphoma by WHO criteria
- Presence of at least one measurable tumor lesion 6 1.5 cm or bone marrow involvement as specified
- Specific prior treatments depending on lymphoma subtype, including chemotherapy, anti-CD20 antibody, and BTK inhibitors as applicable
- Age between 18 and 70 years
- Expected survival of at least 12 weeks
- Adequate liver and kidney function as specified
- ECOG performance status of 0-1
- Left ventricular ejection fraction (LVEF) 6 50% and blood oxygen saturation above 91%
- Agreement to use effective contraception for one year after treatment
- Female participants of childbearing potential must have a negative pregnancy test
- Voluntary participation with signed informed consent
You will not qualify if you...
- Allergy to any components of the cell product
- Grade II-IV acute graft-versus-host disease (GVHD) or recent systemic treatment for GVHD
- Live vaccines within 4 weeks prior to enrollment
- Central nervous system diseases unrelated to lymphoma invasion
- Serious active infections requiring intravenous antibiotics
- Positive hepatitis B or C virus with active infection
- Other immunodeficiency diseases including HIV or active CMV infection
- Severe cardiac insufficiency (NYHA class III or IV)
- History of other primary cancers except certain cured skin or carcinoma in situ cancers
- History of solid organ transplantation
- Previous autoimmune disease or immunosuppressant therapy
- Participation in other interventional clinical trials within 3 months
- Pregnant or breastfeeding women
- Mental illness or central nervous system disorders
- Unresolved treatment toxicity above Grade 2 except alopecia
- Recent use of therapeutic steroid doses or systemic anti-tumor therapy within specified timeframes
- Active pulmonary infection
- Contraindications to peripheral blood apheresis
- Any condition deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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