An Exploratory Clinical Trial of Autologous Humanized Anti-cluster of Differentiation Antigen 19/20(CD19/CD20) Dual Specific CAR-T Cells Injection
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|ClinicalTrials.gov Identifier: NCT04486872|
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma||Biological: Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Dose Escalation Study to Explore Safety, Efficacy and Pharmacokinetics of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma|
|Actual Study Start Date :||July 25, 2020|
|Estimated Primary Completion Date :||May 11, 2022|
|Estimated Study Completion Date :||June 25, 2022|
|Experimental: anti-CD19 and anti-CD20 dual specific CAR-T Cells||
Biological: Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells
Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells injection. Within 3 to 5 days after the pretreatment, the subjects received a single A-02 reinfusion, the infusion dose of each group of subjects 1.00 × 10^6/kg, 3.00 × 10^6/kg or 5.00 × 10^6/kg (if applicable), it is recommended to complete the infusion within 30 min after cell recovery.
- The types and Incidence of adverse events [ Time Frame: Up to 12 months ]Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.
- Duration of overall response [ Time Frame: Up to 12 months ]Time from the first occurrence of CR (complete response) or PR (partial response) to the first diagnosis of PD (progressive disease)or recurrence.
- Overall survival [ Time Frame: Up to 12 months ]Time from randomization to death due to any cause
- Progression-free survival [ Time Frame: Up to 12 months ]Time from enrollment to tumor progression or death.
- Objective response rate [ Time Frame: Up to 12 months ]The proportion of CR (complete response) and PR (partial response).
- Duration of response [ Time Frame: Up to 12 months ]Duration of response is defined as the time from the date of first occurrence of CR (complete response) or PR (partial response) to the date of the first documented PD (progressive disease) or death due to 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): NCT04486872
|Contact: Jie Jin, Profemail@example.com|
|Contact: Jianzhong Shentu, Proffirstname.lastname@example.org|