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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Peter Bergsagel, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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