Description:
This is a Phase 1, multicenter, 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.
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); 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.
Title
- Brief Title: A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma
- 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
Clinical Trial IDs
- ORG STUDY ID:
CC-98633-MM-001
- SECONDARY ID:
U1111-1251-3435
- NCT ID:
NCT04394650
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CC-98633 | | CC-98633 |
Purpose
This is a Phase 1, multicenter, 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.
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); 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.
Trial Arms
Name | Type | Description | Interventions |
---|
CC-98633 | Experimental | Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). | |
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years.
2. Signed written informed consent prior to any study procedure.
3. Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least
3 prior antimyeloma treatment regimens. Subjects must have documented progressive
disease during or within 12 months of completing treatment with the last anti-myeloma
treatment regimen before study entry. Also, subjects with documented evidence of
progressive disease within the previous 6 months and who are refractory or
nonresponsive to their most recent anti-myeloma treatment regimen afterwards will be
also eligible.
Subjects must have previously received all of the following therapies:
1. Autologous stem cell transplant
2. A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide,
pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib),
either alone or combination
3. Anti-CD38 (eg, daratumumab), either alone or combination
4. Measurable disease
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function
Exclusion Criteria:
1. Known active or history of central nervous system (CNS) involvement of MM
2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS
(polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes)
syndrome, or clinically significant amyloidosis
3. Prior treatment with CAR T-cell or another genetically modified T-cell therapy
4. Prior treatment with investigational therapy directed at BCMA
5. Uncontrolled or active infection
6. Active autoimmune disease requiring immunosuppressive therapy
7. 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse Events (AEs) |
Time Frame: | From the time of informed consent and follow up to 2 years after infusion of CC-98633: |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | The proportion of subjects with a partial response (PR) or better by the IMWG criteria. |
Measure: | Complete Response (CR) Rate |
Time Frame: | Up to 2 years after CC-99633 infusion |
Safety Issue: | |
Description: | The proportion of subjects achieving stringent CR or CR. |
Measure: | Duration of response (DOR) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death. |
Measure: | Time to response (TTR) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR). |
Measure: | Time to complete response (TTCR) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Time from CC-98633 infusion to the first documentation of sCR or CR |
Measure: | Progression free survival (PFS) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first |
Measure: | Overall survival (OS) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Time from CC-98633 infusion to death |
Measure: | Pharmacokinetics - maximum serum concentration (Cmax) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Maximum blood concentration |
Measure: | Pharmacokinetics -time to peak serum concentration (tmax) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Time to peak (maximum) blood concentration |
Measure: | Pharmacokinetics - Area under curve (AUC) |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Area under the curve |
Measure: | Very good partial response (VGPR) or better |
Time Frame: | Up to 2 years after CC-98633 infusion |
Safety Issue: | |
Description: | Is define as proportion of subjects achieving sCR, CR, or VGPR |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Juno Therapeutics, a Subsidiary of Celgene |
Trial Keywords
- Multiple Myeloma
- Myeloma
- Myeloma Multiple
- CC-98633
- BCMA
- CAR-T
- CART
- BCMA CART
- BCMA CAR-T
Last Updated
July 20, 2021