RAPA-201 T Cell Therapy for Relapsed, Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04176380|
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed, Refractory Multiple Myeloma||Biological: RAPA-201 Autologous T cells||Phase 2|
This is an open-label, single-arm, non-randomized multicenter Phase 2 study evaluating RAPA-201 cells in subjects with relapsed, refractory multiple myeloma.
After a subject consents to the study, an apheresis procedure will be performed to collect cells to manufacture the investigational product, RAPA-201 cells. During Cycle 1, subjects will receive pentostatin and low-dose, dose-adjusted Cyclophosphamide (PC regimen), but will not receive RAPA-201 cells. During Cycles 2 and beyond, Subjects will receive a conditioning regimen consisting of the PC regimen followed by the RAPA-201 cell infusions.
Subjects will receive at minimum five cycles of treatment. If a subject has stable disease, they will receive an additional four cycles of PC regimen+RAPA-201 cells.
All subjects who complete the active treatment portion of the study, prematurely terminate the study, or subjects who discontinue active treatment due to a toxicity attributable or related to the study drug will complete the follow-up portion of the study (approximately one year).
Patients who experience progressive disease will be taken off study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No Masking|
|Official Title:||Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of Relapsed, Refractory Multiple Myeloma|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
|Experimental: Administration of RAPA-201 cells||
Biological: RAPA-201 Autologous T cells
Autologous rapamycin resistant Th1/Tc1 cells
Other Name: RAPA-201 cells
- Overall response rate [ Time Frame: One (1) year after last dose of RAPA-201 cells. ]To determine the overall response rate, as evaluated by IMWG criteria, in patients with relapse, refractory multiple myeloma (RRMM) treated with autologous RAPA-201 cells and a pentostatin-cyclophosphamide (PC) host conditioning regimen.
- Effect of therapy on disease control [ Time Frame: One (1) year after the last dose of RAPA-201 cells. ](1) To determine the effect of therapy on multiple myeloma disease control, including duration of response (DOR; time from initial tumor response to disease progression).
- Effect in Quality of Life [ Time Frame: One (1) year after the last dose of RAPA-201 cells. ]To evaluate the effect of therapy on quality of life (QOL) using the FACT-BMT questionnaire.
- Immune reconstitution [ Time Frame: Screening; Day 1 of every treatment cycle; End of treatment; Day 1 of Months 1, 3, 9 and 12 of Follow-up. ]Immune reconstitution of participants receiving RAPA-201 cells will be measured using flow cytometry to obtain the absolute number of circulating CD4+ and CD8+ T cells per microliter of blood.
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): NCT04176380
|Contact: Jennifer Gough Clinical Regulatory Coordinator||(617)email@example.com|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Binod Dhakal Principal Investigator, MD 414-805-0505 firstname.lastname@example.org|
|Principal Investigator: Binod Dhakal, MD|
|Study Director:||Daniel Fowler, M.D.||Rapa Therapeutics LLC|