Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Public ClinicalTrials.gov record NCT03430011. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.
Study identification
- NCT ID
- NCT03430011
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 165 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2018
- Primary completion
- Mar 29, 2023
- Completion
- Mar 29, 2023
- Last update posted
- May 23, 2024
2018 – 2023
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0006 | Birmingham | Alabama | 10016 | — |
| Local Institution - 0007 | Duarte | California | 91010 | — |
| Local Institution - 0059 | Los Angeles | California | 90095-1678 | — |
| Local Institution - 0010 | San Francisco | California | 94158 | — |
| Local Institution - 0060 | Denver | Colorado | 80218 | — |
| Local Institution - 0042 | Atlanta | Georgia | 30322 | — |
| Local Institution - 0016 | New Lenox | Illinois | 60451 | — |
| Local Institution - 0061 | Indianapolis | Indiana | 46202 | — |
| Local Institution - 0053 | Westwood | Kansas | 66205 | — |
| Local Institution - 0009 | Baltimore | Maryland | 21231 | — |
| Local Institution - 0005 | Boston | Massachusetts | 02114 | — |
| Local Institution - 0062 | Detroit | Michigan | 48201 | — |
| Local Institution - 0054 | Rochester | Minnesota | 55905 | — |
| Local Institution - 0038 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 0013 | Buffalo | New York | 14263 | — |
| Local Institution - 0001 | New York | New York | 10065 | — |
| Local Institution - 0058 | Portland | Oregon | 97201-3098 | — |
| Local Institution - 0023 | Seattle | Washington | 98104 | — |
| Local Institution - 0018 | Seattle | Washington | 98109 | — |
| Local Institution - 0055 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03430011, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2024 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03430011 live on ClinicalTrials.gov.