A Study of EXP039 Treatment in Subjects With r/r NHL Subjects
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|ClinicalTrials.gov Identifier: NCT04693676|
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : April 13, 2021
This is a single-arm, open label, dose escalation, phase I study of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.
Condition of disease:B cell Non-Hodgkin's Lymphoma Intervention/treatment: Biological/Vaccine: CD19/CD20-direct CAR-T cells. phase: phase 1
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's B-cell Lymphoma||Biological: CD19/CD20-directed CAR-T cells||Phase 1|
This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of EXP039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled.
Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of EXP039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to EXP039 infusion. All subjects who have received EXP039 infusion will be followed for up to 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Evaluating Safety and Efficacy of EXP039 Treatment in Subjects With Relapsed and/or Refractory NHL|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||July 10, 2022|
|Estimated Study Completion Date :||October 10, 2022|
Autologous EXP039 administered by intravenous (IV) infusion
Biological: CD19/CD20-directed CAR-T cells
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Other Name: EXP039
- MTD [ Time Frame: up to12 Months ]maximum tolerated dose or clinical recommended dose
- DLT [ Time Frame: up to 28 days after EXP039 infusion ]Dose limiting toxicity
- AE/SAE/AESI [ Time Frame: up to12 Months ]adverse events (AE), serious adverse event (SAE), pay particular attention to adverse events (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.
- EXP039 CAR expansion and persistence [ Time Frame: up to12 Months ]After EXP039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo.
- Objective response rate (ORR) [ Time Frame: Time Frame 4weeks,12 weeks, 6 months, 9 months, 12 months ]Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
- Duration of response (DOR) [ Time Frame: Time Frame: up to 12 months ]The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion
- Progression-free survival (PFS) [ Time Frame: Time Frame: 4weeks, 12 weeks, 6 months, 9 months ,12 months ]The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
- Overall survival rate (OSR) [ Time Frame: Time Frame: 12 weeks, 6 months, 12 months ]The time from EXP039 infusion to the date of death
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): NCT04693676
|Contact: Jie Jin, PhD&MDfirstname.lastname@example.org|
|First Affiliated Hospital of Zhejiang University College of Medicine||Recruiting|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Jie Jin, PhD&MD +86-0571-87236702 email@example.com|
|Principal Investigator:||Jie Jin, PhD&MD||First Affiliated Hospital of Zhejiang University College of Medicine|