A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant

NCT05393804 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-118
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to see if the quality of T cells used to create ide-cel (bb2121) affects how ide-cel prevents cancer from coming back in people with relapsed or refractory multiple myeloma (MM), and who have had a hematopoietic cell transplant.

Conditions

Multiple Myeloma

Keywords

Ide-cel (bb2121); Hematopoietic Cell Transplant; 22-118

Outcome Measures

Primary Outcomes (1)

• feasibility of manufacturing Ide-Cel (to dose of at least 300 million cells)

  Success for the feasibility endpoint is defined as collecting and manufacturing at least 300 x10\^6 Ide-Cel cells.

  1 year

Secondary Outcomes (1)

• best overall response rate (ORR)

  12 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants with relapsed/refractory MM who had an autologous hematopoietic stem cell transplant (AHCT). In an AHCT, their own blood-forming stem cells are collected. Participants are then treated with high doses of chemotherapy which kills the cancer cells, but it also gets rid of the blood-producing cells that are left in the bone marrow. Afterward, the collected stem cells are put back into the bloodstream, allowing the bone marrow to produce new blood cells.

Biological: Ide-cel (bb2121)

Cohort 2

EXPERIMENTAL

Participants with relapsed/refractory MM who had an allogeneic hematopoietic cell transplant (alloHCT). In an alloHCT, a person's stem cells are replaced with new, healthy stem cells from a donor.

Biological: Ide-cel (bb2121)

Interventions

Ide-cel (bb2121) BIOLOGICAL

Eligible patients will undergo leukapheresis, receive lymphodepleting (LD) chemotherapy followed by infusion of Ide-Cel or Cilta-Cel, and be monitored daily for 14 days, three times a week until day + 30 after CAR T infusion and monthly until 12 months post CAR T infusion.

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Cohort 1:
• Patient with myeloma who has received at least four prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and had measurable disease prior to salvage high dose melphalan autoHCT done within the prior 2 - 6 months. (Salvage melphalan/AutoHCT can count as the 4th line of treatment).
• Measurable disease is defined by any of the following:
• M-spike ≥ 0.5mg/dL
• Urine m-spike ≥ 200mg/dL/24 hours
• Involved Serum Free light chain ≥ 10mg/dL
• Measurable plasmacytoma on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm).
• Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining
• Cohort 2:
• Patients with pathologically confirmed MM who have received at least 4 prior lines of treatment having been exposed to an IMID, PI, and a CD38 monoclonal antibody and have undergone an allo HCT for RRMM at any time in their history and have at least minimal residual disease by flow or NGS in the bone marrow at least 3 months after allo HCT.
• Prior to Leukapheresis:
• Greater than age 18.
• Karnofsky performance ≥ 70.
• Recovered to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding Grade 2 neuropathy
• Not receive any systemic anti-myeloma therapy for 14 days prior to leukapheresis. Therapeutic doses of corticosteroids (defined as greater than 10 mg/day prednisone or equivalent) are permitted until within 72 hours prior to Leukapheresis.

You may not qualify if:

• Receiving any of the following less than 14 days prior to enrollment:
• Plasmapheresis
• Major surgery (as defined by the investigator)
• Radiation therapy other than local therapy for MM-associated bone lesions
• Prior organ transplant requiring systemic immunosuppressive therapy
• History of ≥ Grade 2 hemorrhage within 30 days of enrollment
• Patient requiring ongoing treatment with chronic, therapeutic dosing of anticoagulants (e.g., Warfarin, low molecular weight heparin, Factor Xa inhibitors) can be enrolled with approval of the PI.
• History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
• Having concurrent Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
• History of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or hemodynamically significant ventricular arrhythmia within the previous 6 months prior to enrollment
• Active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible. Patients with a history of acute or chronic GVHD are potentially eligible if on minimal immunosuppressants as defined previously.
• Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B or C, or acute hepatitis A. If any history of exposure to hepatitis B or C, then DNA PCR should be negative. If hepatitis B core Ab positive with negative DNA PCR, patients should be on prophylaxis while on study.
• Prior malignancies except resected basal cell carcinoma or treated carcinoma in situ. Cancer treated with curative intent less than 5 years prior to enrollment will not be allowed unless approved by the PI. Cancer treated with curative intent greater than 5 years prior to enrollment is allowed.
• Female patients who are breastfeeding or who intend to become pregnant during participation in the study.
• Known allergy or hypersensitivity to any of the study medications, their analogues, or excipients in the various formulations of any agent.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel

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

Study Officials

• Gunjan Shah, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two cohort feasibility trial with 15 patients in each cohort to assess the ability to produce and manufacture anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T cells (idecabtagene vicleucel, Ide-Cel) in patients with multiple myeloma (MM).

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: May 20, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)