Multiple MyelomaPhase 2NCT05393804
A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant
A Phase 2 study testing Ide-cel (bb2121) in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ide-cel (bb2121)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 May 2022to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: Feasibility Trial of Autologous Anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy Using Ide-Cel for Multiple Myeloma Patients Status Post Hematopoietic Cell Transplantation
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
- Being tested
- Ide-cel (bb2121)
- Keywords
- Ide-cel (bb2121), Hematopoietic Cell Transplant, 22-118
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Ide-cel (bb2121) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
best overall response rate (ORR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start20 May 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunjan Shah, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393804
- Sponsor's protocol ID
- 22-118
- Status last verified
- Apr 2026
- First submitted
- 23 May 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Autologous Anti-B Cell Maturation Antigen Chimeric Antigen Receptor T Cell Therapy Using Ide-Cel for Multiple Myeloma Patients Status Post Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05393804
- Acronym / sponsor ID
- 22-118
- Conditions
- Multiple Myeloma
- Keywords
- Ide-cel (bb2121), Hematopoietic Cell Transplant, 22-118
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Ide-cel (bb2121)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. |
| Cohort 2 | Experimental | Biological: Ide-cel (bb2121)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (59 listed)
- 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:
- 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:
- Hepatic Function:
Key exclusion criteria (21 listed)
- Receiving any of the following less than 14 days prior to enrollment:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ide-cel (bb2121)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. | Biological | Cohort 1, Cohort 2 |
Primary outcome
feasibility of manufacturing Ide-Cel (to dose of at least 300 million cells)
Time frame: 1 year
Success for the feasibility endpoint is defined as collecting and manufacturing at least 300 x10^6 Ide-Cel cells.
1 secondary outcome
best overall response rate (ORR)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunjan Shah, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ide-cel (bb2121) in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 59 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of manufacturing Ide-Cel (to dose of at least 300 million cells) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.