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CAR T-cell Therapy

CAR T-Cell Therapy for Central Nervous System Lymphoma

Phase 1

Waitlist Available

Led By Caron Jacobson, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy. There is no restriction on the number of recurrences.

Age 18 years or older at the time of informed consent

Must not have

History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Patients with brain stem lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is being done to test the safety and effectiveness of axicabtagene ciloleucel, an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy, in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma. The trial will also assess neurological toxicity following treatment with axi-cel.

Who is the study for?

Adults over 18 with relapsed/refractory central nervous system (CNS) lymphoma or systemic lymphoma with CNS involvement, who've had at least one prior treatment. They must have adequate organ function, no severe infections, and not be pregnant or breastfeeding. Excluded are those with certain heart conditions, active infections requiring IV treatment, history of other cancers within 3 years (except some skin cancers), and those unable to undergo MRI.

What is being tested?

The trial is testing axicabtagene ciloleucel (axi-cel), a CAR T-cell therapy targeting CD19 in patients with specific types of CNS lymphomas that have returned after treatment. It includes pre-treatment drugs cyclophosphamide and fludarabine to enhance the effectiveness of axi-cel.

What are the potential side effects?

Potential side effects include neurological toxicity which can affect brain function, immune reactions causing inflammation in various organs including the heart and lungs, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, allergic reactions to infusion components.

Eligibility Criteria

Inclusion Criteria

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

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My brain lymphoma has returned or didn't respond after treatment.

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I am 18 years old or older.

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My lymphoma is aggressive and has come back or didn't respond to treatment.

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My CNS lymphoma has returned or didn't respond after treatment.

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I am fully active or can carry out light work.

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My heart pumps well, and I have no serious heart fluid buildup or ECG issues.

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My kidneys are functioning well.

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I do not have serious fluid buildup in my chest.

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My oxygen level is above 92% without assistance, and I haven't used GCSF or transfusions for this condition.

Exclusion Criteria

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

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I have a history of serious brain or nerve conditions.

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I have a lesion in my brain stem.

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I have had CAR-T cell therapy or other genetic modifications to my T-cells.

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I have had a stem cell transplant from a donor.

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I have previously received treatment targeting CD19.

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I have a significant brain or spinal cord tumor or my CSF protein is high.

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I have been cancer-free for 3 years, except for non-dangerous skin cancers or early-stage cancers.

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I haven't taken any immune-boosting drugs in the last 6 weeks or before their effects wore off.

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I have HIV or hepatitis B/C, but if treated, my viral load is undetectable.

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I cannot have MRI scans due to my condition.

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My CLL has transformed into a more aggressive form.

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I do not have any serious infections, or if I do, they are under control with treatment.

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I have active tuberculosis.

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My lymphoma affects my heart's atrium or ventricle.

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I need urgent treatment because my tumor is causing symptoms.

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I am on blood thinners due to a serious clot in my veins or lungs.

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I have not received a live vaccine in the last 6 weeks and do not plan to during the study.

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My cancer has spread to the lining of my brain and spinal cord but not into the brain tissue itself.

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I have an autoimmune disease and have been on systemic treatment in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

Secondary study objectives

Complete response (CR) rate

Duration of response (DOR)

Objective response rate (ORR)

+2 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 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

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: Fludarabine + Cyclophosphamide + Axicabtagene CiloleucelExperimental Treatment3 Interventions

Prior to receiving axi-cel, participants will undergo leukapheresis and the need for a Ommaya reservoir placement will be assessed and administered. Day -5 to Day -3 of 28 day study cycle Fludarabine and cyclophosphamide; Day -1 admitted to hospital, receive axi-cel on day 0; Till at least cycle day 7 hospital monitoring; post treatment follow up will occur on day 14 and day 28 of cycle 1, monthly in cycles 2, 3, 6, 9,12,15,18,21,24, then yearly after cycle 24.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Axicabtagene ciloleucel

FDA approved

Fludarabine

FDA approved

0 / 28Eligibility criteria met