Actively Recruiting
CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-07-16
80
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD20 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
CONDITIONS
Official Title
CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand and voluntarily sign the informed consent form and agree to follow study visits, treatment, and tests
- Confirmed CD19+ or CD20+ B cell hematological tumor with relapsed or refractory disease
- For B lymphocytic leukemia: relapse within 6 months of first remission, or no complete remission after 2 chemotherapy cycles, or no remission after salvage chemotherapy, or not eligible for or relapsed after stem cell transplant
- For B-cell lymphoma: less than 50% tumor shrinkage or progression after 4 chemotherapy courses, or relapse within 6 months after complete remission, or two or more relapses, or not suitable for or relapsed after stem cell transplant; must have prior treatment including anti-CD20 antibody and anthracycline chemotherapy
- Diagnosed with B-cell acute lymphoblastic leukemia, indolent B-cell lymphoma, or invasive B-cell lymphoma
- Have measurable or evaluable lesions (lymphoma with lesions ≥15mm or multiple lesions ≥10mm; leukemia with persistent or recurrent bone marrow minimal residual disease)
- Have an ECOG fitness score of 0 to 2
- Positive tumor antigen test for CD19 or CD20
- Estimated survival longer than 3 months from consent signing
You will not qualify if you...
- Recent or ongoing serious heart problems including atrial fibrillation, heart attack within 12 months, prolonged QT syndrome, low heart function, significant pericardial effusion, or severe heart failure
- Active graft versus host disease
- History of severe lung function impairment
- Advanced stage of other malignant tumors
- Severe or uncontrolled infections
- Severe autoimmune disease or innate immune deficiency
- Active hepatitis B or C infection with abnormal liver function
- HIV or syphilis infection
- History of severe allergies to biological products including antibiotics
- Central nervous system disorders such as uncontrolled epilepsy, stroke, dementia, or cerebellar disease
- Women who are pregnant, breastfeeding, or planning pregnancy within 12 months
- Any condition that may increase risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
M
Mei Heng, M.D., Ph.D
CONTACT
Y
Yun Kang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here