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Completed

NCT Number: NCT04394650

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants 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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 103, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

i) 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

Exclusion criteria

  • 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

Treatment and study plan

CC-98633

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 2 years after CC-98633 infusion

    The proportion of subjects with a partial response (PR) or better by the IMWG criteria.

  2. Complete Response (CR) Rate

    Time frame: Up to 2 years after CC-99633 infusion

    The proportion of subjects achieving stringent CR or CR.

  3. Duration of response (DOR)

    Time frame: Up to 2 years after CC-98633 infusion

    The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.

  4. Time to response (TTR)

    Time frame: Up to 2 years after CC-98633 infusion

    Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR).

  5. Time to complete response (TTCR)

    Time frame: Up to 2 years after CC-98633 infusion

    Time from CC-98633 infusion to the first documentation of sCR or CR

  6. Progression free survival (PFS)

    Time frame: Up to 2 years after CC-98633 infusion

    Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first

  7. Overall survival (OS)

    Time frame: Up to 2 years after CC-98633 infusion

    Time from CC-98633 infusion to death

  8. Pharmacokinetics - maximum serum concentration (Cmax)

    Time frame: Up to 2 years after CC-98633 infusion

    Maximum blood concentration

  9. Pharmacokinetics -time to peak serum concentration (tmax)

    Time frame: Up to 2 years after CC-98633 infusion

    Time to peak (maximum) blood concentration

  10. Pharmacokinetics - Area under curve (AUC)

    Time frame: Up to 2 years after CC-98633 infusion

    Area under the curve

  11. Very good partial response (VGPR) or better

    Time frame: Up to 2 years after CC-98633 infusion

    Is define as proportion of subjects achieving sCR, CR, or VGPR

Sponsors and collaborators

Lead sponsor

Juno Therapeutics, a Subsidiary of Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 19, 2020
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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