A Study to Evaluate CC-98633 to Treat Subjects with Relapsed and/or Refractory Multiple Myeloma

Overview

Información sobre este estudio

The purpose of this Phase 1 first-in human study is to evaluate the safety and preliminary efficacy of CC-98633 in adult subjects with relapsed and/or refractory MM. A challenge in CAR T-cell development is to generate a product that consistently expands, persists, and mediates durable antitumor responses after infusion. Multiple preclinical and translational studies have suggested that the differentiation state of adoptively transferred T cells can influence the ability of these cells to persist and promote durable antitumor immunity. Less differentiated T cells have shown an increased ability to proliferate, persist, and mediate responses in mouse tumor models compared to more differentiated effector memory cell subsets in certain studies.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

1. Age ≥ 18 years.

2. Signed written informed consent prior to any study procedure.

3. Relapsed and/or refractory multiple myeloma (MM).

1. 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.

2. Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior
antimyeloma treatment regimens.

3. 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.

4. 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.

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. Part A and Part B Cohort A only: 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Shaji Kumar, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Peter Bergsagel, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20493136

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