A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04129099|
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia||Biological: GC022F||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||June 2022|
Experimental: CAR-T treatment group
The patients will receive one dose of GC022F. GC022F dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg.
GC022F is the CAR-T cell immunotherapy targeted CD19 and CD22. The subjects will receive GC022F as one dose. The dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg.
- Incidence and severity of treatment related Adverse Events, CRS and Neurotoxicity (Safety and tolerability) [ Time Frame: 2 years ]Adverse events(AEs) will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except CRS/ICANS )
- CAR copies and concentration of GC022F in peripheral blood, bone marrow and CSF (amplification and persistence) [ Time Frame: 2 years ]GC022F CAR copies and cells in peripheral blood, bone marrow and CSF will be measured by qPCR and FCM in 2 years
- Overall response rate of patients who received GC022F infusion (efficacy) [ Time Frame: 2 years ]Overall response rate will be estimated as the percents of patients who achieved CR or CRi.
- Concentraiton of anti-GC022F antibody after infusion (humoral immune response) [ Time Frame: 2 years ]After GC022F infusion, GC022F antibody in peripheral blood will be measured in 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129099
|Contact: Junfang Yang, Bachelor||13522084342||Yangjunfang77@163.com|
|Hebei Yanda Ludaopei Hospital||Recruiting|
|Sanhe, Hebei, China, 065200|
|Contact: Peihua Lu, PhD&MD +86-0316-3306393|
|Principal Investigator:||Junfang Yang, Bachelor||Hebei Yanda Ludaopei Hospital|