NCT04394650CompletedPhase 1
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase I, Multi Center, Open Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 26 Jul 2024
Brief summary (registry, in English)
This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose RP2D(s); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D(s).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 14 May 2020
- Start date
- 18 Aug 2020
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Diseases
- Multiple myeloma
- NCT number
- NCT04394650
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 78
- From 18 Aug 2020 to the primary completion date, 3 Jul 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with CAR T-cell or another genetically modified T-cell therapy
- Part A and Part B Cohort A only: Prior treatment with investigational therapy directed at BCMA
Other illness
- Known active or history of central nervous system (CNS) involvement of MM
- Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
- Uncontrolled or active infection
- Active autoimmune disease requiring immunosuppressive therapy
- History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Who the study is looking for
- Age ≥ 18 years.
- Signed written informed consent prior to any study procedure.
- Relapsed and/or refractory multiple myeloma (MM).
- Subjects must have documented progressive disease as per International Myeloma Working Group (IMWG) criteria during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with confirmed progressive disease within 6 months prior to start of Screening and who are refractory (or non-responsive) to their most recent anti-myeloma treatment regimen afterwards will be also eligible.
- Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens.
- Part B Cohort B only: Subjects must have received at least 1 but no greater than 3 prior antimyeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
- Subjects must have previously received all of the following therapies:
- Autologous stem cell transplant ii) A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination iii) Anti-CD38 (eg, daratumumab), either alone or combination Subjects in Cohort B do not require prior anti-CD38 antibody therapy.
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.