CAR-T Therapy for Multiple Myeloma

Recruiting at 15 trial locations

Overseen By Megan Scott

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Marcelo Pasquini, MD

Must be taking: Lenalidomide

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: CNS involvement, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).

Research Team

Sergio Giralt, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Marcelo C Pasquini, MD, MS

Principal Investigator

Medical College of Wisconsin

Alfred Garfall, MD

Principal Investigator

University of Pennsylvannia

Eligibility Criteria

Adults over 18 with symptomatic multiple myeloma who've had autologous hematopoietic cell transplant within the last year, are on a lenalidomide maintenance regimen, and have good organ function. They must not be pregnant or breastfeeding and agree to use two forms of birth control. Excluded are those with certain medical conditions, previous gene or BCMA-targeted therapies, uncontrolled infections, or unwillingness to follow study protocols.

Inclusion Criteria

Your blood clotting time is not too fast.

My kidney function, measured by creatinine clearance, is good.

My initial treatment for myeloma didn't fully clear the cancer.

Exclusion Criteria

You have had a previous allogeneic hematopoietic cell transplant.

I stopped taking lenalidomide permanently due to severe side effects.

My multiple myeloma does not produce detectable levels of M protein.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and Manufacturing

Patients undergo leukapheresis for collection of autologous lymphocytes, which are sent to manufacturing facilities

3-4 weeks

Lymphodepleting Chemotherapy

Patients receive cyclophosphamide and fludarabine for 3 consecutive days

1 week

CAR T-cell Infusion

Infusion of BCMA CAR T-cells at a target dose of 450 x106 cells

1 day

Maintenance Therapy

Maintenance lenalidomide is initiated and continues until 12 months post CAR T-cell infusion

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• bb2121
• Lenalidomide

Trial Overview The trial is testing bb2121 CAR-T cells in patients with multiple myeloma post-autologous hematopoietic cell transplant. The goal is to see if this treatment can improve responses in patients already on lenalidomide maintenance therapy. It's a Phase II study where all participants receive the same intervention.

Participant Groups

Group I: Lenalidomide and bb2121 Experimental Treatment 1 Intervention

Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression.

bb2121 is already approved in United States, European Union for the following indications:

Approved in United States as Abecma for:

• Relapsed or refractory multiple myeloma

Approved in European Union as Abecma for:

• Relapsed or refractory multiple myeloma

Who Is Running the Clinical Trial?

Marcelo Pasquini, MD

Lead Sponsor

Trials

1

Recruited

40+

National Marrow Donor Program

Collaborator

Trials

63

Recruited

202,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Blood and Marrow Transplant Clinical Trials Network

Collaborator

Trials

51

Recruited

14,600+

Celgene a wholly owned subsidiary of BMS

Collaborator

Trials

1

Recruited

40+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+