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)

Feasibility Study of 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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma; Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Iberdomide; Procedure: CAR-T Leukapheresis; Procedure: CAR-T Infusion

Detailed Description

In this feasibility study, patients with RRMM planned for standard of care CAR-T will be approached for consent for enrollment. Participating patients will receive one 28-day cycle of iberdomide at a dose of 1.0 mg daily, using a dosing schedule of 1.0 mg once daily for 21 days followed by 7 days off. After completion of the 28-day cycle, patients will proceed with leukapheresis on day 29 of therapy, with allowance for up to a 14-day delay in leukapheresis if needed. Blood samples will be collected on day 1 (prior to iberdomide exposure) and on the day of leukapheresis to compare T cell profiling before and after iberdomide priming. After leukapheresis, patients will proceed with standard of care management, including bridging therapy if indicated, until CAR-T infusion. After infusion, blood samples will be collected daily during initial hospitalization, then weekly for 1 month, and then monthly for up to 1 year. Blood samples will be evaluated for maximal CAR-T and ALC expansion and CAR-T persistence. Patients will be monitored per standard of care protocols for clinical efficacy and toxicity after CAR-T therapy for up to 1 year.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rashmi Unawane; Phone Number: (212) 824-2385; Email: rashmi.unawane@mssm.edu
• Study Contact Backup: Name: Vikram Madan, MPH; Phone Number: (347) 835-3446; Email: vikram.madan@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
      • Contact: Rashmi Unawane; Phone Number: 212-824-2385; Email: Rashmi.Unawane@mssm.edu
      • Contact: Vikram Madan; Phone Number: (646) 745-6092; Email: Vikram.Madan@mssm.edu
      • Principal Investigator: Shambavi Richard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

• 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.

EXCLUSION CRITERIA

• 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.
  • Localized prostate cancer (N0M0):
  • with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,
  • with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or
  • any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI
  • Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
  • Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.
  • Any other cancer from which the subject has been disease free for > 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.
• Prior treatment with Iberdomide (CC-220) within 6 months prior to enrollment
• Prior allogeneic stem cell transplant except subjects who have completed the stem cell transplant > 12 months prior to first dose of study drug, have no history of graft versus host disease, and are not on systemic immunosuppressive therapy
• Major cardiac surgery within 8 weeks prior to the first dose of study drug; all other major surgery within 4 weeks prior to the first dose of study drug.

• Subjects with following physical and laboratory test findings:

  • Absolute neutrophil count < 1 x 109/L without growth factor support within 1 week, or absolute neutrophil count < 0.5 x 109/L for patients with documented Duffy-null blood typing
  • Platelets < 50 x 109/L without transfusion support within 1 week
  • Creatinine clearance < 30 ml/min according to the Cockroft-Gault formula:
• Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dl]

• Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dl]

  • Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)
  • AST or ALT ≥ 3x ULN
  • Corrected serum calcium > 13.5 mg/dL

• Are also excluded:

  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with RRMM; 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; 1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle; Other Names: CC-220; Procedure: CAR-T Leukapheresis; 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.; Procedure: CAR-T Infusion; Participants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proportion of T cell subsets from baseline after iberdomide priming	Proportion of T cell subsets (including terminally differentiated effector, exhausted, and activated T cells) present for each participant in the feasibility evaluable (FE) population at leukapheresis (Priming D29 after iberdomide) to baseline (Priming-D1).	On the day of leukapheresis, after completing iberdomide therapy on Day 29
Cmax with iberdomide priming prior to leukapheresis	Cmax is the highest measured concentration of iberdomide. Cmax will be assessed in the CAR-T evaluable (CARTE) population	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
Tmax with iberdomide priming prior to leukapheresis,	Time to reach Cmax. Tmax will be assessed in CAR-T (CARTE) population	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
AUC0-14 with iberdomide priming prior to leukapheresis	Total Exposure over time. AUC0-14 will be assessed in the CAR-T evaluable (CARTE) population.	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
CAR-T persistence with iberdomide priming prior to leukapheresis,	CAR-T persistence will track therapy effectiveness over time. CAR-T persistence will be assessed in the CAR-T evaluable (CARTE) population.	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
ALCmax with iberdomide priming prior to leukapheresis	Absolute Lymphocyte Count (ALC) is a key blood test measuring the exact number of lymphocytes. ALCmax measures the maximum count overtime. ALCmax will be assessed in the CAR-T evaluable (CARTE) population.	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
Time to ALCmax with iberdomide priming prior to leukapheresis	Time to reach absolute lymphocyte count maximum (ALCmax) in the CAR-T evaluable (CARTE) population.	After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
Absolute lymphocyte count (ALC) expansion kinetics as a proxy for CAR-T expansion		After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12
Overall response rate	Overall response rate (ORR), defined as the proportion of patients that achieve at least a partial response according to IMWG criteria	After CAR-T at Day 100 (~Month 3) and Month 12
Measurable residual disease	Rate of measurable residual disease (MRD)-negativity and MRD-negative complete response (CR) as defined by IMWG response criteria	After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.
Progression-free survival	Progression-free survival (PFS), defined as the time from CAR-T infusion until progression by IMWG response criteria or death	After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.
Overall survival	Overall survival (OS), defined as the time from CAR-T infusion until death	After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.
Duration of response	Duration of response (DOR), defined as time from first observed response after CAR-T until progression by IMWG criteria	After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.
Time to next treatment	Time to next treatment (TTNT), defined as the time from CAR-T infusion until initiation of the next line of myeloma-directed therapy for subsequent relapsed disease	After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

Collaborators and Investigators

• Sponsor: Shambavi Richard
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Shambavi Richard, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

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Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Multiple myeloma; Iberdomide; CC-220; Relapsed/refractory multiple myeloma; CAR-T therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Investigative Techniques; Therapeutics; Biological Therapy; Immunologic Techniques; Immunomodulation; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; iberdomide; Immunotherapy, Adoptive
• Other Study ID Numbers: Study-26-00586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The completed dataset is the sole property of the Sponsor-Investigator's institution and should not be exported to third parties, except for authorized representatives of appropriate Health/Regulatory Authorities, without permission from the Sponsor-investigator and their institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No