Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a supercharged immune cell keep myeloma away after transplant?

NCT ID NCT05393804

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a personalized cell therapy called Ide-Cel (CAR T) in people with multiple myeloma who have already had a stem cell transplant. The goal is to see if the therapy can be made successfully and help prevent the cancer from returning. About 24 participants will receive their own modified immune cells to target and destroy myeloma cells.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

May 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 without filgrastim use in the prior 14 days. * Hemoglobin ≥ 8 g/dL (without red blood cell transfusion in the previous 7 days) * Creatinine Clearance (CrCl) ≥ 45 mL/min, measured or estimated by Cockcroft-Gault equation. * Corrected serum calcium ≤ 13.5 mg/dL * Oxygen saturation ≥ 92% on room air * Hepatic Function: * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN * Serum total bilirubin Serum total bilirubin ≤ 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN 2 x ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN * International ratio (INR) or partial thromboplastin time (PTT) ≤ 1.5 x ULN * Cardiac Function: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA). * Willing and able to adhere to the study visit schedule and other protocol requirements including regulatory requirement of a 15 year follow up using the CIBMTR long term follow up mechanism. * Female patients of childbearing potential (FCBP) must: * Have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL prior to enrollment * Agree to use, and be able to comply with, TWO acceptable methods of birth control, one highly effective method and one additional effective (barrier) method AT THE SAME TIME, from screening through at least 1 year following Ide-Cel infusion * Agree to abstain from breastfeeding from screening through at least 1 year following Ide-Cel infusion * Male patients must: * Agree to use a condom during sexual contact with a pregnant female or a FCBP, even if he has undergone a successful vasectomy, from screening through at least 1 year following Ide-Cel infusion * Must not donate sperm from screening through at least 1 year following Ide-Cel infusion * Prior to LD Chemotherapy * Females of childbearing potential must have a negative serum pregnancy test ≤ 7 days prior to LD chemotherapy * Platelet count ≥ 50,000/mm\^3 (transfusion allowed) * ANC ≥ 1,000/mm\^3 (without filgrastim within 72 hours) * Hepatic Function: * Serum AST and ALT ≤ 2.5 × ULN * Serum total bilirubin ≤ 2 × ULN. Patients who have been diagnosed with Gilbert's disease are permitted to exceed the defined bilirubin value of 2 x ULN * CrCl ≥ 45 mL/min, measured or estimated by Cockcroft-Gault equation * INR or PTT ≤ 1.5 x ULN * No history of ≥ Grade 2 hemorrhage within 30 days * No presence of active/uncontrolled infection requiring systemic therapy. Prophylactic antimicrobials are allowed. * No intercurrent illness or toxicity that would place the subject at undue risk of proceeding to LD chemotherapy * Must not be taking therapeutic doses of corticosteroids (defined as greater than 10 mg/day prednisone or equivalent) within 72 hours prior to LD chemotherapy. Physiologic replacement, topical, intranasal and inhaled steroids are permitted. Patients on calcineurin inhibitors (cyclosporine or tacrolimus) should have levels considered undetectable per institutional criteria * No active urinary outflow obstruction * Availability of manufactured cells * Patients not meeting these criteria may still be eligible to initiate LD chemotherapy with the approval of the Protocol PI (Principal Investigator). * Prior to Ide-Cel or Cilta-Cel infusion * Subjects who meet at least one of the following criteria on the day of scheduled CAR T cell infusion should have its administration delayed: * Suspected or active systemic infection * Onset of fever ≥ 38°C * Requirement for supplemental oxygen to keep saturation greater than 91% * Cardiac arrhythmia not controlled with medical management * Hypotension requiring vasopressor support * New onset or worsening of other non-hematologic organ dysfunction ≥ Grade 3 * Taking any of the prohibited medications as described in Section 15 * Significant worsening in clinical status compared to initial eligibility criteria that would, in the opinion of the treating physician, increase the risk of adverse events associated with Ide-Cel or Cilta-Cel infusion. Exclusion Criteria: * 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. * Serious medical of psychiatric illness likely to interfere with participation on this clinical study * Uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment. * Unwilling or unable to provide informed consent * Unable or unwilling to return to the center for treatment and follow up * No systemic anti-myeloma therapy is allowed within 7 days prior to leukapheresis. Steroids are allowed, but should be tapered off by 72 hours prior to leukapheresis. * Steroids are allowed between leukapheresis and LD chemotherapy, but should be tapered off by 72 hours prior to lymphodepletion.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.