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Monoclonal Antibodies

Emapalumab for Low Blood Cell Count

Phase 2

Recruiting

Led By Paolo Strati, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Postmenopausal (no menses in greater than or equal to 12 consecutive months)

Age ≥ 18 years

Must not have

Women of child-bearing potential who are pregnant or breastfeeding

Grade 3-4 cytopenia due to use of experimental non-commercially available CART product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether emapalumab is safe and effective in treating severe low blood cell counts in people with a certain type of lymphoma who have undergone CART therapy.

Who is the study for?

This trial is for individuals with LBCL who have severe, prolonged low blood cell counts after CAR T-cell therapy. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

What is being tested?

The trial is testing emapalumab to see if it's safe and can help treat people with long-lasting severe cytopenia (low white blood cells, anemia, low platelet count) following CAR T-cell therapy for LBCL.

What are the potential side effects?

Potential side effects of emapalumab aren't listed here, but they may include reactions at the injection site, immune system responses, or infections due to changes in blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I have not had a menstrual period for at least 12 months.

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I am 18 years old or older.

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My lymphoma has returned or didn't respond to treatment.

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I have been treated with axi-cel, tisa-cel, or liso-cel.

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My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).

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I have ovarian failure due to radiation therapy.

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I have had a procedure done to prevent pregnancy permanently.

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I am able to care for myself and perform daily activities.

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My heart pumps well and I don't have fluid around it.

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I have had a hysterectomy or both ovaries removed.

Exclusion Criteria

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

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I am pregnant or breastfeeding.

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I have severe low blood cell counts from a trial CAR T-cell therapy.

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My low blood cell counts are due to cancer, an enlarged spleen, HLH, or another cancer like MDS.

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My CLL has transformed into a more aggressive form.

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I have severe low blood cell counts before starting chemotherapy for CAR T-cell therapy.

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My lymphoma is getting worse and needs treatment right away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and adverse events (AEs)

Side effects data

From 2021 Phase 2 & 3 trial • 58 Patients • NCT02069899

29%

Viral upper respiratory tract infection

14%

Dental caries

14%

Cholelithiasis

14%

Headache

14%

Still's disease

Condition aggravated

Nausea

Epstein-Barr virus infection

Rhinovirus infection

Rash erythematous

Enterovirus infection

Viral infection

Adverse event following immunisation

Arthritis

Osteonecrosis

Dysphonia

Oedema peripheral

Pyrexia

Arthralgia

Oropharyngeal pain

Urticaria

Lymphopenia

Skin laceration

Rash papular

Rectal prolapse

Cestode infection

Blood alkaline phosphatase increased

100%

80%

60%

40%

20%

Study treatment Arm

Enrolled-06 Cohort

Enrolled-CU Cohort

Enrolled-04 Cohort

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: EmapalumabExperimental Treatment1 Intervention

If you are found to be eligible to take part in this research study, you will be assigned to 1 of 2 dose levels of emapalumab, based on when you enroll on the study. Up to 16 participants will receive each dose level of the study drug. * The first group of 5 participants will be enrolled at the lower dose level. * Depending on the safety data seen in this first group, the next 11 participants will be enrolled at the lower dose. * After reviewing the early safety data from that first group of 16 participants, the study team will enroll the next 5 participants at the higher dose level and be checked for serious side effects. * Depending on the safety information from the first 5 participants in the higher dose level group, the other 11 will then be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emapalumab

2014

Completed Phase 3

~110

0 / 16Eligibility criteria met