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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

Must not have

Subject with specific medical history or conditions including CNS involvement, plasma cell leukemia, inadequate organ function, HIV, uncontrolled infections, prior history of malignancies, pregnancy, lactation, known hypersensitivity, and prior history of DVT or PE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 2 years after bb2121 infusion

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of severe illnesses, infections, or other health conditions listed.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Overall response rate (ORR)- Cohort 1

Secondary study objectives

Adverse Events (AEs)

Complete response (CR) rate - Cohort 1

Duration of response (DoR)

+15 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

645 Previous Clinical Trials

129,920 Total Patients Enrolled

146 Trials studying Multiple Myeloma

41,542 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

1,582 Previous Clinical Trials

3,388,337 Total Patients Enrolled

77 Trials studying Multiple Myeloma

28,855 Patients Enrolled for Multiple Myeloma

Media Library

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

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