Actively Recruiting
CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-16
80
Participants Needed
1
Research Sites
164 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 \& CD22 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 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed CD19-positive or CD22-positive B cell hematological tumor by pathology and histology
- Relapsed or refractory B lymphocytic leukemia meeting at least one of the following: relapse within 6 months of first remission; no complete remission after 2 cycles of standard chemotherapy; no remission or relapse after salvage chemotherapy; not eligible for or relapse after hematopoietic stem cell transplantation (HSCT)
- Relapsed or refractory B-cell lymphoma meeting criteria including less than 50% tumor shrinkage or progression after 4 chemotherapy courses; relapse within 6 months after complete remission; two or more recurrences; unsuitable for or relapse after HSCT; prior treatment with anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy
- Positive tumor antigen results by flow cytometry or immunohistochemistry for CD19 or CD22
- Estimated survival greater than 3 months from consent
- Good organ function defined as hemoglobin ≥70 g/L (transfusible); creatinine ≤1.5 times upper limit of normal (ULN); total bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN; left ventricular ejection fraction >50%; blood oxygen saturation >90%
- ECOG performance status 0 to 2
You will not qualify if you...
- Serious heart insufficiency with left ventricular ejection fraction <50%
- History of severe pulmonary function impairment
- Advanced stage of other malignant tumors
- Severe or uncontrolled persistent 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
- Acute graft-versus-host disease within one month after stopping immunosuppressants
- Other serious physical or mental conditions or lab abnormalities increasing risk or interfering with study participation as judged by 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
H
Heng Mei, 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
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