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Monoclonal Antibodies

Flotetuzumab for CD123-Positive Hematological Malignancies

Phase 1

Waitlist Available

Led By Ibrahim T Aldoss

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

- Hodgkin lymphoma patients who have failed or relapsed after PD-1/PD-L1- inhibitors and brentuximab vedotin

Hairy cell leukemia patients who have failed or progressed shortly after purine analogs or failed 2 cycles of purine analog

Must not have

Use of immunosuppressant medications (other than steroid as noted above) in the 2 weeks prior to study drug administration (Cycle 1 Day 1)

Females only: Pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the best dose and side effects of flotetuzumab for treating patients with relapsed or refractory blood cancers. Flotetuzumab is an antibody that may interfere with cancer cells' ability to grow and spread.

Who is the study for?

This trial is for adults with advanced blood cancers expressing CD123 who have not responded to standard treatments or whose disease has returned. Eligible participants must meet specific health criteria, including organ function and blood counts, and agree to use effective birth control. Those with recent transplants, untreated autoimmune disorders, active infections, or certain other medical conditions are excluded.

What is being tested?

The trial is testing the optimal dose and side effects of flotetuzumab in patients with various hematological malignancies that express CD123. Flotetuzumab is a monoclonal antibody designed to inhibit cancer cell growth. The study includes supportive medications like acetaminophen and dexamethasone to manage potential reactions.

What are the potential side effects?

Possible side effects of flotetuzumab may include allergic reactions similar to those caused by compounds related to it. Patients might also experience symptoms from the immune system attacking their own body (autoimmune disorders), infusion-related reactions, or worsening of underlying diseases.

Eligibility Criteria

Inclusion Criteria

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

Select...

My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.

Select...

My hairy cell leukemia didn't respond to or got worse after purine analog treatment.

Select...

My BPDCN has returned or didn't respond to the first treatment.

Select...

My BPDCN has returned or didn't respond to the first treatment.

Select...

I have advanced acute leukemia that didn't respond to two previous treatments.

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My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.

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My blood cancer is CD123+ and has not responded to standard treatments, but it's not AML or MDS.

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I have had at least one treatment for my relapsed or refractory T-cell cancer.

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I have CML and cannot use or did not respond to the latest treatment.

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I have had at least one treatment for my relapsed or refractory condition.

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I have recovered from side effects of cancer treatment, except for hair loss.

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My systemic mastocytosis worsened despite midostaurin treatment.

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My tumor tests positive for CD123.

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My hairy cell leukemia didn't respond to or got worse after purine analog treatment.

Select...

My white blood cell count is healthy for treatment.

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My acute leukemia is advanced and has not responded to two previous treatments.

Select...

I have CML and cannot use or did not respond to the latest treatment.

Select...

My Hodgkin lymphoma did not respond to PD-1/PD-L1 inhibitors or brentuximab vedotin.

Select...

I have acute lymphoblastic leukemia.

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I have ALL, failed 2 treatments, and can't have CD19 therapy.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My systemic mastocytosis worsened despite taking midostaurin.

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My cancer can be measured and is at least 1.5 cm on a scan.

Select...

I have ALL, failed 2 treatments, and can't have CD19 therapy.

Exclusion Criteria

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

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I haven't taken any immunosuppressant drugs, except steroids, in the last 2 weeks.

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I am not pregnant or breastfeeding.

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I do not have any active, untreated autoimmune disorders except for vitiligo.

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I am mentally capable of understanding and giving informed consent.

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My heart is healthy and functions well.

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I currently have an infection that isn't under control.

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I haven't had certain immune treatments in the last 28 days, except for blinatumomab which was not in the last 14 days.

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I am receiving treatment for another cancer, but hormone therapy is okay.

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I have serious lung problems.

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I do not have any uncontrolled serious illnesses.

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I am taking more than 10 mg/day of oral prednisone or its equivalent, excluding inhalers, nasal sprays, or eye drops.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

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

Incidence of adverse events

Secondary study objectives

Best response of complete remission attained

Duration of remission

Minimal residual disease

+2 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 (flotetuzumab)Experimental Treatment6 Interventions

INDUCTION THERAPY: Patients receive flotetuzumab via continuous IV infusion on days 1-28. Patients who achieve SD/PR (Cohort A) or PR/CI (Cohort B), receive an additional induction cycle. Patients who achieve PR (Cohort A) or PR/CI/MMR (Cohort B) after cycle 2 re-induction, may continue induction therapy for up to 4 more cycles. CONSOLIDATION THERAPY: Patients who achieve CR/CRi/CRh/MLFS (Cohort A) or CR/MR (Cohort B) after cycle 1 or cycle 2 of induction therapy, receive flotetuzumab via continuous IV infusion on days 1-28 for up to 5 and 6 cycles, respectively, in the absence of disease progression or unacceptable toxicity. Patients with PR (Cohort A) or PR/CI/MMR (Cohort B) who have received up to 6 cycles of induction therapy may receive up to 2 cycles of consolidation therapy in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Acetaminophen

2017

Completed Phase 4

~2030