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CAR T-cell Therapy

bb2121 for Multiple Myeloma (KarMMa-2 Trial)

Phase 2

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)

Subject must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 2 years after bb2121 infusion

Awards & highlights

KarMMa-2 Trial Summary

This trial is testing a new treatment for myeloma that has relapsed or is refractory. The trial will enroll approximately 235 subjects in 3 different cohorts.

Who is the study for?

This trial is for adults over 18 with Multiple Myeloma that's come back or didn't respond to treatment, including those who've had a stem cell transplant. It's not for those who've recently used investigational drugs, have certain medical conditions like organ failure or uncontrolled infections, are pregnant or breastfeeding, or have a history of blood clots.Check my eligibility

What is being tested?

The study tests bb2121 and Lenalidomide in different groups: one with relapsed/refractory myeloma after multiple treatments; others with early relapse post-transplant; and some with inadequate response to initial transplant therapy. The goal is to see how well these treatments work and their safety.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues like nausea or diarrhea, nerve damage symptoms such as numbness or tingling.

KarMMa-2 Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older.

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I am fully active and can carry on all pre-disease activities without restriction.

KarMMa-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 2 years after bb2121 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum of 2 years after bb2121 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 2 years after bb2121 infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete response (CR) rate - Cohort 1b, 2a, 2b, 2c, and Cohort 3

Overall response rate (ORR)- Cohort 1

Secondary outcome measures

Adverse Events (AEs)

Complete response (CR) rate - Cohort 1

Duration of response (DoR)

+16 more

KarMMa-2 Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myelomaExperimental Treatment2 Interventions

Group II: Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCTExperimental Treatment1 Intervention

Group III: Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participantsExperimental Treatment1 Intervention

Group IV: Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participantsExperimental Treatment1 Intervention

Group V: Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participantsExperimental Treatment2 Interventions

Group VI: Cohort 1: BB2121 in relapsed and refractory multiple myeloma participantsExperimental Treatment1 Intervention

bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bb2121

2017

Completed Phase 2

~230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,590 Total Patients Enrolled

142 Trials studying Multiple Myeloma

40,599 Patients Enrolled for Multiple Myeloma

Lars Sternas, MD, PhDStudy DirectorCelgene

3 Previous Clinical Trials

569 Total Patients Enrolled

3 Trials studying Multiple Myeloma

569 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,616 Total Patients Enrolled

72 Trials studying Multiple Myeloma

25,023 Patients Enrolled for Multiple Myeloma

Media Library

bb2121 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03601078 — Phase 2

$Multiple Myeloma Research Study Groups: Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT, Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants, Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants, Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants, Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants, Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma$

Multiple Myeloma Clinical Trial 2023: bb2121 Highlights & Side Effects. Trial Name: NCT03601078 — Phase 2

bb2121 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03601078 — 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 in this experiment?

"That is correct, the relevant information on clinicaltrials.gov affirms that this study remains open and is actively recruiting participants. The trial was first advertised on December 13th, 2018 and received its most recent edit on June 23rd, 2022. A total of 235 patients are needed for the experiment, which will take place across 24 different locations."

Answered by AI

Are investigators still looking for participants for this experiment?

"That is correct. The online clinicaltrial database has the latest information on this trial, which was originally posted on December 13th, 2018. As of June 23rd, 2022, the study is still looking for 235 patients from 24 different sites."

Answered by AI

What are the typical conditions that bb2121 helps to improve?

"bb2121 is most often used to treat multiple myeloma that has not responded to other treatments. It can also be taken to treat patients that have previously undergone proteasome inhibitor treatment, anti-cd38 monoclonal antibody treatment, or who have had ≥4 lines of therapy."

Answered by AI

Is this a novel clinical trial?

"Since 2015, bb2121 has undergone extensive clinical trials. The first sponsored by Celgene was completed in that same year and included 67 participants. Following the success of the initial study, Phase 1 drug approval was granted. Currently, there are 8 active global trials involving 54 cities and 13 countries."

Answered by AI

Are there any sites running this trial in North America?

"This trial is being conducted at University of Texas Southwestern Medical Center in Dallas, Texas; Massachusetts General Hospital in Boston, Massachusetts; Dana Farber Cancer Institute in Seattle, Washington and additional 24 locations."

Answered by AI

Are there any past case studies of bb2121's efficacy?

"The first trial for bb2121 was conducted in 2015 at Beth Israel Deaconess Medical Center. There have been no completed trials as of now, however there are 8 live studies with a large number being run out of Dallas, Texas."

Answered by AI

What is the bb2121 drug's official government classification?

"bb2121 is still being tested for both efficacy and safety. However, there is already some data supporting its safety profile, so it received a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma

2018. "An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03601078.

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