A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03767751|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: Dual Specificity CD38 and bcma CAR-T Cells||Phase 1 Phase 2|
- To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.
- To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.
- SECONDARY OBJECTIVES:
1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.
2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||December 5, 2022|
|Estimated Study Completion Date :||December 5, 2022|
- Biological: Dual Specificity CD38 and bcma CAR-T Cells
1) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg
- Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24weeks ]
- MTD of dual specificity CD38 and BCMA CAR-T cells [ Time Frame: 4 weeks ]The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells
- Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes [ Time Frame: 24 weeks ]
- Six-month Objective response rate of complete remission and partial remission [ Time Frame: 24 weeks ]
- Six-month Overall survival [ Time Frame: 24 weeks ]
- Six-month Progression free survival [ Time Frame: 24 weeks ]
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): NCT03767751
|Contact: YaJing Zhangfirstname.lastname@example.org|
|Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Weidong Han 86-10-13651392893 email@example.com|