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CAR T-cell Therapy

Ide-cel Combination Therapy for Multiple Myeloma (KarMMa-7 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Participant has documented diagnosis of MM and measurable disease

Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Participant has non-secretory MM or has history of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis

Participant has any of the following laboratory abnormalities: ANC and Platelets count as reported below, Hemoglobin < 8 g/dL, Creatinine clearance (CrCl) as reported below, Corrected serum calcium > 13.5 mg/dL, Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 ×upper limit of normal (ULN), Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for participants with documented Gilbert's syndrome, International normalized ratio (INR) or activated partial thromboplastin time (aPTT) 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or participant requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors), Participant has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air, Participant has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal, Prior exposure to CC-220 (± low-dose dexamethasone) as part of their most recent antimyeloma treatment regimen (Arm A), Prior exposure to BMS-986405 (JSMD194) (Arm B), Previous history of an allogeneic hematopoietic stem cell transplantation, treatment with any gene therapy-based therapeutic for cancer, investigational cellular therapy for cancer or BCMA targeted therapy, Participant has received autologous stem cell transplantation (ASCT) within 12 weeks prior to leukapheresis for Treatment Arm A Cohort 1 and Arm B, Participant has received autologous stem cell transplantation (ASCT) within 12 months prior to leukapheresis for Treatment Arm A Cohort 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months after bb2121 infusion in the respective cohort

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of a new drug, bb2121, in combination with other therapies, in adult patients with relapsed or refractory multiple myeloma. There are three arms in the trial testing different combinations of drugs. The study will first determine the best dose of bb2121 (Phase 1), and then expand to testing the efficacy of the combinations in a larger group of patients (Phase 2).

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma (R/RMM) who've had at least one prior treatment. They should have shown some response to previous treatments and currently show disease progression. Good physical condition (ECOG 0-1) is required, but those with certain blood conditions, severe liver issues, recent bleeding events or specific past treatments like gene therapy are excluded.

What is being tested?

The study tests bb2121 combined with other drugs in two arms: Arm A pairs it with CC-220 (with/without dexamethasone), while Arm B uses BMS-986405. It's a phase 1/2 trial aiming to find the right doses and expand testing based on safety and effectiveness results from earlier phases.

What are the potential side effects?

Potential side effects aren't specified here, but generally for cancer trials like this they can include fatigue, nausea, immune system reactions, infusion-related reactions from the drug combinations being tested, as well as impacts on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma and it can be measured.

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I am fully active or can carry out light work.

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I've been treated with specific cancer drugs for at least 2 cycles.

Exclusion Criteria

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

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I have a specific blood cancer type, not the common multiple myeloma.

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If you have any of the following issues in your blood, kidney function, liver function, or clotting, or if you have certain lung or previous treatment problems, you may not be able to participate in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months after bb2121 infusion in the respective cohort

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months after bb2121 infusion in the respective cohort

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months after bb2121 infusion in the respective cohort 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 Rate (CRR)_ Phase 2

Does Limiting Toxicity (DLT) rates _Phase 1

Secondary study objectives

Duration of Response (DoR)

Feasibility of maintenance therapy in combination with bb2121

Incidence of Adverse Event (AEs)

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B- bb2121 in combination with BMS-986405 (JSMD194)Experimental Treatment2 Interventions

* bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered during Month 1 starting from the day of bb2121 infusion * Enrollment is closed for this Arm

Group II: Arm A- bb2121 in combination with CC-220 (± low-dose dexamethasone)Experimental Treatment2 Interventions

bb2121 will be administered at a target dose of 450 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules, depending on dose limiting toxicity (DLT) evaluation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-220

2016

Completed Phase 2

~620

0 / 5Eligibility criteria met