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CAR T-cell Therapy

Ide-cel (bb2121) for Multiple Myeloma

Phase 2

Recruiting

Led By Gunjan Shah, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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, 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, Corrected serum calcium ≤ 13.5 mg/dL, Oxygen saturation ≥ 92% on room air

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test if a certain type of T-cell is more effective than another in preventing cancer relapse in patients with multiple myeloma.

Who is the study for?

This trial is for adults over 18 with multiple myeloma who've had a cell transplant and at least four prior treatments including specific drugs. They must have recovered from previous treatment side effects, not be on certain medications, and agree to birth control measures. Pregnant or breastfeeding women, those with severe heart conditions or active infections, and individuals with other cancers are excluded.Check my eligibility

What is being tested?

The study tests if T cells used to create the drug ide-cel (bb2121) can prevent cancer recurrence in patients with relapsed/refractory multiple myeloma post-cell transplant. It examines the quality of T cells' impact on ide-cel's effectiveness.See study design

What are the potential side effects?

Potential side effects of ide-cel include reactions related to immune system activation such as fever, fatigue, digestive issues; risk of infection; blood disorders; neurological events; and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have MM, treated with 4+ lines including IMID, PI, CD38 antibody, had allo HCT, and show minimal disease post 3 months of HCT.

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Your liver and heart function tests must be within a certain range, and you need to commit to regular study visits and follow-up for 15 years.

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I agree to use protection during sex and not donate sperm for 1 year after my treatment.

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Before starting LD chemotherapy, females who could become pregnant must have a negative pregnancy test and meet certain blood test values. They must also have good liver and kidney function, and cannot have certain medical conditions or be taking specific medications. If someone does not meet these criteria, they may still be able to start LD chemotherapy with the approval of the study's main doctor.

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I am not pregnant, can follow strict birth control methods for a year, and won't breastfeed.

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I do not have a fever, infection, need extra oxygen, uncontrolled heart issues, severe blood pressure problems, or worsening organ function.

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I have myeloma, treated with 4+ therapies including IMID, PI, CD38 antibody, and had a recent autoHCT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

best overall response rate (ORR)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

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.

Group II: Cohort 1Experimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,135 Patients Enrolled for Multiple Myeloma

Gunjan Shah, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

76 Total Patients Enrolled

2 Trials studying Multiple Myeloma

44 Patients Enrolled for Multiple Myeloma

Media Library

Ide-cel (bb2121) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05393804 — Phase 2

Multiple Myeloma Research Study Groups: Cohort 1, Cohort 2

Multiple Myeloma Clinical Trial 2023: Ide-cel (bb2121) Highlights & Side Effects. Trial Name: NCT05393804 — Phase 2

Ide-cel (bb2121) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393804 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are taking part in this experiment?

"That is right, the information available on clinicaltrials.gov shows that this research is actively seeking volunteers. The listing was published on May 20th, 2022 and updated most recently on July 6th, 2022. So far, only 30 of the required participants have been recruited from a single site."

Answered by AI

Are patients able to sign up for this experimental treatment at this time?

"That is accurate. The clinicaltrials.gov website has the latest information on this trial, which was created on 5/20/2022 and updated most recently on 7/6/2022. They are looking for 30 individuals total from 1 location."

Answered by AI

What are the risks someone might face by taking Ide-cel (bb2121)?

"Ide-cel (bb2121) is still being clinically tested for both safety and efficacy. However, there is already some data supporting its safety, which gives it a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05393804.