A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- NHL
|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: NCT04412174|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-cell Non Hodgkin Lymphoma||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- NHL|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
The patients will receive GC022F CAR-T treatment. GC022F dosage ranges from 3×10^5 to 1×10^6 CAR+T/Kg.
GC022F is a bispecific CAR-T cell immunotherapy that targeted CD19 and CD22. The dosage ranges from 3×10^5 to 1×10^6 CAR+T/Kg.
- Type and incidence of DLT, incidence and severity of treatment related AE, CRS and Neurotoxicity (Safety and tolerability) [ Time Frame: 2 years ]AE 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 of GC022F in peripheral blood, bone marrow, CSF and tumor tissue (amplification and persistence) [ Time Frame: 2 years ]GC022F CAR copies in peripheral blood, tumor tissue, bone marrow and CSF will be measured by qPCR in 2 years.
- CAR cells of GC022F in peripheral blood, bone marrow and CSF (amplification and persistence) [ Time Frame: 2 years ]GC022F CAR cells in peripheral blood, bone marrow and CSF will be measured by FCM in 2 years.
- Objective response rate (ORR) (efficacy) [ Time Frame: 3 months ]ORR will be calculated as the percents of patients who achieved CR or PR.
- Duration of Response (DOR) (efficacy) [ Time Frame: 2 years ]DOR will be calculated as the time from the first assessment of CR or PR to the first assessment of relapse or death from any cause.
- Progression-Free Survival (PFS) (efficacy) [ Time Frame: 2 years ]PFS will be calculated as the time from CAR-T infusion to disease progression or death from any cause (whichever occurs first).
- Overall Survival (OS) (efficacy) [ Time Frame: 2 years ]OS will be calculated as the time from CAR-T infusion to death from any cause.
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): NCT04412174
|Contact: Peihua Lu, PhD&MD||+86-0316-3306393||Peihua_lu@126.com|
|Hebei Yanda Ludaopei Hospital|
|Sanhe, Hebei, China, 065200|
|Contact: Peihua Lu, PhD&MD +86-0316-3306393|
|Principal Investigator:||Peihua Lu, PhD&MD||Hebei Yanda Ludaopei Hospital|