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Trial Title:
CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors
NCT ID:
NCT06503094
Condition:
B-Cell Lymphoblastic Leukemia/Lymphoma
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
CAR-T
dual-target
Relapsed / Refractory B Cell Hematological Tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD19&CD20 bispecific CAR-T cells
Description:
Each patient will receive CD19&CD20 bispecificCAR-T cells by intravenous infusion on day
0.
Arm group label:
Effective of CD19&CD20 bispecific CAR-T cells
Summary:
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.
Detailed description:
Since 2010, CAR-T ( chimeric antigen receptor T cell) therapy has shown good results in
tumor treatment and has achieved positive clinical therapeutic effects in hematological
tumors. The structure of the dual-target CAR-T of CD19 & CD20 is designed with a 4-1BB
costimulatory domain and an antigenic recognition region with a tandem structural
sequence to recognize CD20 or CD19 by a single structure. CD19 & CD20 bispecific CAR-T
cells can identify CD 19 or CD 20 with the advantage that the single target CAR-T does
not have, reducing the possibility of target loss. The structure has been optimized to
enhance the safety to treat B cell-derived hematological tumors (at least CD19 positive
or CD20 positive).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Fully understand and voluntarily sign the informed consent form, and be willing and
able to comply with the visit, treatment protocol, laboratory tests, and other study
requirements specified in the flow sheet;
- CD 19 + / CD 20 + B cell hematological tumor was confirmed by pathological and
histological examination, and the patient met the following criteria for relapsed or
refractory B cell hematological tumor:
1. Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be
met):
i . Recurrence within 6 months of first remission; ii. Primary refractory
without complete remission after 2 cycles of standard chemotherapy regimen;
iii. No complete remission or recurrence after first-line or multiline salvage
chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or
relapse after HSCT due to conditional limitations.
2. Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4
items plus item 5):
i . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less
than 50% or disease progression; ii . CR after standard regimen chemotherapy, but
relapsed within 6 months; iii.2 or more recurrences after CR; iv . Not suitable for
hematopoietic stem cell transplantation, or abandoning HSCT due to conditional
restrictions or relapse after hematopoietic stem cell transplantation; v . Subject must
have received prior adequate treatment, including at least: a monoclonal antibody against
CD 20 and combination chemotherapy containing an anthracycline drug agent.
- B-cell hematological tumors include the following 3 categories:
1. B-cell acute lymphoblastic leukemia (B-ALL);
2. Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
3. Invasive B-cell lymphoma (DLBCL, BL, and MCL);
- With measurable or evaluable lesions: Lymphoma patients require a single lesion 15mm
or 2 or more lesions 10mm; patients with leukemia require persistent positive or
positive recurrence of bone marrow MRD.
- Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to
2.
- The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 20)
were positive.
- The estimated survival period is more than 3 months starting from the signing of the
informed consent form.
Exclusion Criteria:
- Appearance of one of the following cardiac criteria: atrial fibrillation; myocardial
infarction in the last 12 months; prolonged QT syndrome or secondary QT extension,
as judged by the investigator. Echocardiography LVSF <30% or LVEF <50%; clinically
significant pericardial effusion; cardiac insufficiency NYHA (New York Heart
Association) III or IV (confirmed by echocardiography within 12 months of
treatment).
- Active GVHD.
- History of severe pulmonary function impairment disease.
- Other malignant tumors in the advanced stage.
- Severe infection or persistent infection that cannot be effectively controlled.
- Combined with severe autoimmune disease or innate immune deficiency.
- Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA 500 IU / ml and
abnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA above
the lower limit of detection of the analytical method and abnormal liver function).
- Human immunodeficiency virus (HIV) infection or syphilis infection.
- History of severe allergies to biological products (including antibiotics).
- There are central nervous system disorders, such as uncontrolled epilepsy,
cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, etc..
- Female patients are in pregnancy and lactation, or have a pregnancy plan within 12
months.
- situations where the investigator may increase the risk or interfere with the test
results.
Gender:
All
Minimum age:
14 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Mei Heng, M.D., Ph.D
Email:
hmei@hust.edu.cn
Start date:
January 14, 2024
Completion date:
June 18, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Hebei Taihe Chunyu Biotechnology Co., LTD
Agency class:
Other
Collaborator:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
Jingzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Shiyan People's Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yichang Central People's Hospital
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503094
