Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
NCT ID: NCT03271515
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2021-03-01
2023-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
NCT03881761
Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL
NCT02656147
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
NCT06081478
Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
NCT02546739
CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
NCT06735495
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
conventional therapy
patients accept conventional radioactive and chemical therapy.
No interventions assigned to this group
anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
Exclusion Criteria
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Doing Biomedical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
li gangyi
Role: STUDY_CHAIR
Beijing Doing Biomedical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gai liyun, Docter
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Doing-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.