Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM)

NCT07727668 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: Study-26-00586
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed/refractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Giving iberdomide before CAR-T may improve T cell fitness which may improve CAR-T expansion kinetics and response after infusion.

Conditions

Multiple Myeloma; Relapsed/Refractory Multiple Myeloma

Keywords

Multiple myeloma; Relapsed/refractory multiple myeloma; Iberdomide; CAR-T therapy; CC-220

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming.

  Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming, defined as an absolute increase of \>10 percentage points or a relative increase of \>50% in TEM cells.

  On the day of leukapheresis, after completing iberdomide therapy on Day 29

Secondary Outcomes (14)

• Change in Proportion of T cell subsets from baseline after iberdomide priming

  On the day of leukapheresis, after completing iberdomide therapy on Day 29

• Cmax with iberdomide priming prior to leukapheresis

  After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

• Tmax with iberdomide priming prior to leukapheresis,

  After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

• AUC0-14 with iberdomide priming prior to leukapheresis

  After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

• CAR-T persistence with iberdomide priming prior to leukapheresis,

  After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

Study Arms (1)

Patients with RRMM

EXPERIMENTAL

Patients with RRMM who are already planned for standard-of-care CAR-T therapy. Study participants will be planned for one cycle (28 days) of iberdomide therapy (1.0mg daily on days 1-21 of a 28-day cycle), followed by CAR-T leukapheresis. Patients will then proceed with CAR-T infusion per standard of care, with additional lab monitoring for T cell phenotyping and CAR-T expansion kinetics.

Drug: Iberdomide; Procedure: CAR-T Leukapheresis; Procedure: CAR-T Infusion

Interventions

Iberdomide DRUG

1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle

Also known as: CC-220

Patients with RRMM

CAR-T Leukapheresis PROCEDURE

A procedure in which blood is collected and white blood cells (including T cells) are separated and collected. The remaining blood components are returned to the participant. The collected T cells will be used to manufacture the CAR-T cell therapy.

Patients with RRMM

CAR-T Infusion PROCEDURE

Participants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells

Patients with RRMM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel.
• All subjects must have ≥2 prior lines of multiple myeloma directed therapy, as determined by their treating clinician
• All patients must have ECOG Performance Status ≤ 2.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy tests (minimum sensitivity 25 IU/L or equivalent units of hCG), at screening (10-14 days prior to start of study drug); another within 24 hours prior to the start of study drug.
• Women must not be breastfeeding
• WOCBP must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 1 month (4 weeks) after completion of iberdomide.
• Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy. Male patients must not donate sperm.
• Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
• All subjects must agree not to share study medication.

You may not qualify if:

• Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
• Subjects with active Central Nervous System involvement with multiple myeloma
• Subjects with active multiple myeloma that cannot be safely managed with single-agent iberdomide for the duration of the priming period, per the discretion of the treating physician or PI
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
• Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI
• Subjects with an active infection that requires parenteral anti-infective treatment within 7 days
• Unable to tolerate thromboembolic prophylaxis while on iberdomide
• Severe hypersensitivity reaction to prior IMiD (thalidomide, lenalidomide or pomalidomide)
• Grade \> 2 peripheral neuropathy (per NCI CTCAE v5.0)
• Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.
• Patients with detectable HIV viral load or known acquired immunodeficiency syndrome (AIDS).
• Prior or concurrent malignancy, except for the following:
• Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.
• Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.

Sponsors & Collaborators

• Shambavi Richard: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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Related Links

• Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. U.S. Dept. of Health \& Human Services, NIH, NCI; 2017.

MeSH Terms

Conditions

Multiple Myeloma

Interventions

iberdomide; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Shambavi Richard, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikram Madan, MPH

CONTACT

(347) 835-3446; vikram.madan@mssm.edu

Rashmi Unawane

CONTACT

(212) 824-2385; rashmi.unawane@mssm.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)