Multiple MyelomaPhase 1NCT04394650
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing CC-98633 in people with Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CC-98633
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Aug 2020to 3 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
- 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
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Local Institution - 103
Birmingham, Alabama, 35233
Local Institution - 106
Buffalo, New York, 14263
Local Institution - 108
Charlotte, North Carolina, 28204
Local Institution - 107
Chicago, Illinois, 60637
Local Institution - 105
Dallas, Texas, 75390
Local Institution - 104
New York, New York, 10029
Local Institution - 102
New York, New York, 10065
Local Institution - 111
Phoenix, Arizona, 85054
Local Institution - 109
Rochester, Minnesota, 55905
Local Institution - 110
Stanford, California, 94305
Local Institution - 101
Westwood, Kansas, 66205-2003
About this study
Official title: 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
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).
- Conditions
- Multiple Myeloma
- Being tested
- CC-98633
- Keywords
- Multiple Myeloma, Myeloma, Myeloma Multiple, CC-98633, BCMA, CAR-T, CART, BCMA CART, BCMA CAR-T
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-98633Biological
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC-98633.
During CC-98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC-98633 product, subjects will receive treatment with CC-98633 therapy.
Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection.
| Study group | Role | What they receive |
|---|---|---|
| CC-98633 | Experimental | Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Receives: Biological: CC-98633 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
incidence and severity of AEs. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From the time of informed consent and follow up to 2 years after infusion of CC-98633:
Secondary outcomes (11)
Overall Response Rate (ORR)
The proportion of subjects with a partial response (PR) or better by the IMWG criteria.
Measured: Up to 2 years after CC-98633 infusion
Complete Response (CR) Rate
The proportion of subjects achieving stringent CR or CR.
Measured: Up to 2 years after CC-99633 infusion
Duration of response (DOR)
The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.
Measured: Up to 2 years after CC-98633 infusion
Time to response (TTR)
Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR).
Measured: Up to 2 years after CC-98633 infusion
Time to complete response (TTCR)
Time from CC-98633 infusion to the first documentation of sCR or CR
Measured: Up to 2 years after CC-98633 infusion
Progression free survival (PFS)
Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Measured: Up to 2 years after CC-98633 infusion
Overall survival (OS)
Time from CC-98633 infusion to death
Measured: Up to 2 years after CC-98633 infusion
Pharmacokinetics - maximum serum concentration (Cmax)
Maximum blood concentration
Measured: Up to 2 years after CC-98633 infusion
Pharmacokinetics -time to peak serum concentration (tmax)
Time to peak (maximum) blood concentration
Measured: Up to 2 years after CC-98633 infusion
Pharmacokinetics - Area under curve (AUC)
Area under the curve
Measured: Up to 2 years after CC-98633 infusion
Very good partial response (VGPR) or better
Is define as proportion of subjects achieving sCR, CR, or VGPR
Measured: Up to 2 years after CC-98633 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start18 Aug 2020
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394650
- Sponsor's protocol ID
- CC-98633-MM-001
- Other IDs
- U1111-1251-3435
- Status last verified
- Jul 2024
- First submitted
- 14 May 2020
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04394650
- Acronym / sponsor ID
- CC-98633-MM-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Myeloma, Myeloma Multiple, CC-98633, BCMA, CAR-T, CART, BCMA CART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Juno Therapeutics, a Subsidiary of CelgeneIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-98633 | Experimental | Biological: CC-98633Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Signed written informed consent prior to any study procedure.
- Relapsed and/or refractory multiple myeloma (MM).
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (7 listed)
- 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
- 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
- Uncontrolled or active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-98633Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC-98633. During CC-98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC-98633 product, subjects will receive treatment with CC-98633 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection. | Biological | CC-98633 |
Primary outcome
Adverse Events (AEs)
Time frame: From the time of informed consent and follow up to 2 years after infusion of CC-98633:
incidence and severity of AEs. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
11 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 2 years after CC-98633 infusion
Complete Response (CR) Rate
Time frame: Up to 2 years after CC-99633 infusion
Duration of response (DOR)
Time frame: Up to 2 years after CC-98633 infusion
Time to response (TTR)
Time frame: Up to 2 years after CC-98633 infusion
Time to complete response (TTCR)
Time frame: Up to 2 years after CC-98633 infusion
Progression free survival (PFS)
Time frame: Up to 2 years after CC-98633 infusion
Overall survival (OS)
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics - maximum serum concentration (Cmax)
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics -time to peak serum concentration (tmax)
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics - Area under curve (AUC)
Time frame: Up to 2 years after CC-98633 infusion
Very good partial response (VGPR) or better
Time frame: Up to 2 years after CC-98633 infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-98633 in people with Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: From the time of informed consent and follow up to 2 years after infusion of CC-98633:). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.