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CAR T-cell Therapy

CAR T-Cells for Blood Cancer

Phase 1

Recruiting

Led By Mohamed A. Kharfan-Dabaja, M.D., M.B.A.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of relapsed or refractory B-cell hematologic malignancies including CLL/SLL, FL, MCL, MZL, or LBCL

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Must not have

Autologous HCT ≤ 60 days prior to pre-registration

Prior allogeneic hematopoietic stem cell transplant (HCT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with certain types of blood cancer that has come back or does not respond to other treatments. The treatment involves changing the patient's immune system cells in the laboratory

Who is the study for?

This trial is for patients with various B-cell blood cancers that have either returned after treatment or haven't responded to previous treatments. Participants must meet specific health criteria not detailed here.

What is being tested?

The trial is testing a new therapy where patient's T-cells are modified in the lab to attack cancer cells, combined with chemotherapy drugs fludarabine and cyclophosphamide to prepare the body for these engineered T-cells.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; chemotherapy-related nausea, hair loss, and increased infection risk; plus procedure-specific risks.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of B-cell blood cancer that has come back or didn’t respond to treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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My disease has come back or didn't respond to treatment.

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My liver is working within normal ranges.

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My test for BAFFR is positive.

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I am 18 years old or older.

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My kidney function is within normal ranges.

Exclusion Criteria

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

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I had a stem cell transplant using my own cells less than 60 days ago.

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I have had a stem cell transplant from a donor.

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I have had a solid organ transplant.

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I have not received treatments targeting BAFF-R before.

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I cannot have chemotherapy that reduces my white blood cells due to health reasons.

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I have recently undergone radiation therapy.

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I am HIV positive.

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I am not pregnant or breastfeeding.

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I have a serious illness that is not related to my heart.

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My cancer has spread to my brain or spinal fluid.

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I have an active hepatitis B or C infection.

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I have severe heart failure.

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I currently have an infection that is not under control.

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I have heart conditions or fluid around my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and severity of treatment emergent adverse events

Incidence of dose-limiting toxicities (DLT)

Secondary study objectives

Complete response rate

Duration of response

Number of conforming versus nonconforming products

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (BARRF based chimeric antigen receptor T-cells)Experimental Treatment12 Interventions

Patients undergo leukapheresis. Patients then receive cyclophosphamide IV, over 60 minutes and fludarabine IV over 30 minutes on day -5 to -3 or bendamustine IV over 10 minutes on days -4 and -3. Patients receive BAFFR based chimeric antigen receptor T-cells IV on day 0. Patients undergo echocardiography and MRI at screening, CT scan, PET scan, bone marrow biopsy/aspirate and blood sample collection throughout the study and tumor biopsy at progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

Cyclophosphamide

2010

Completed Phase 4

~2310