A Clinical Research of CD20-Targeted CAR-T in B Cell Malignancies
NCT ID: NCT02710149
Last Updated: 2019-06-25
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/PHASE2
45 participants
INTERVENTIONAL
2016-03-31
2021-03-31
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.
A Clinical Research of CD30-Targeted CAR-T in Lymphocyte Malignancies
NCT02958410
A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
NCT02349698
A Clinical Research of BCMA-Targeted CAR-T in B Cell Malignancies
NCT02954445
A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies
NCT02935153
Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies
NCT03262298
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
B Cell Malignancies
The trial will be conducted in a manner of simon two-stage design with Anti-CD20-CAR-transduced T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with B cell malignancies. Only when the expected reaction rate is achieved the 30 patients left can be recruited.
Anti-CD20-CAR-transduced T cells
Patients receive autologous-derived CD20-targeted CAR-T cells on day 1, 2 after receiving lymphodepleting chemotherapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anti-CD20-CAR-transduced T cells
Patients receive autologous-derived CD20-targeted CAR-T cells on day 1, 2 after receiving lymphodepleting chemotherapy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients enrolled must have an evaluated score above 60 with KPS.
3. CD20 expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry. In general immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.
4. Gender is not limited, age from 14 years to 75 years.
5. Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
6. Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
7. Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
8. Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of \< 5/uL WBCs in CSF and cytospin positive for blasts, or \> 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
9. Patients with isolated CNS relapse will be eligible if they have previously been treated with cranial radiation (at least 1800 cGy).
10. Ability to give informed consent.
11. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
13. Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
14. Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
15. Patients volunteer to participate in the research.
Exclusion Criteria
1. Patients are evaluated below 60 scores with KPS.
2. Evident signs suggesting that patients are potentially allergic to cytokines.
3. Frequent infection history and recent infection is uncontrolled.
4. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
5. Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
6. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
7. Pregnancy and nursing females.
8. HIV infection.
9. Active hepatitis B or active hepatitis C.
10. Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
11. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
12. Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
13. Other situations we think not eligible for participation in the research.
14 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Southwest Hospital, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shiqi Li
Researcher of Biotherapy Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cheng Qian, MD, PhD
Role: STUDY_CHAIR
Biotherapy Center of Southwest Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 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.
Zhi Yang, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TMMU-BTC-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.