Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)
NCT ID: NCT03173417
Last Updated: 2019-05-20
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.
COMPLETED
PHASE1/PHASE2
177 participants
INTERVENTIONAL
2017-05-23
2019-05-01
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.
Safety and Efficacy Evaluation of IM19 CAR-T Cells
NCT03142646
Safety and Efficacy Evaluation of IM19 Cells
NCT03344705
Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
NCT05309213
CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients
NCT03902197
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
NCT05640713
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.
IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
IM19 CAR-T
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
fludarabine and cyclophosphamide
Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IM19 CAR-T
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
fludarabine and cyclophosphamide
Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
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. To be aged 3 to 75 years
3. Blast in blood ≤ 30%
4. ECOG score ≤2
5. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
6. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion Criteria
2. Respiratory failure
3. CD19 negative
4. Disseminated intravascular coagulation
5. ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x normal value
6. Hematosepsis or Uncontrolled active infection
7. Uncontrolled diabetes
8. Abalienation;
9. WHO Sscore \>3
10. Patients in pregnancy or breast-feeding period
11. Previously treatment with any gene therapy products
12. Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
13. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
3 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Immunochina Medical Science & Technology 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.
PEIHUA LU, MD
Role: PRINCIPAL_INVESTIGATOR
Hebei Yanda Ludaopei Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hebei Yanda Ludaopei Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21.
Zhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YMCART201702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.