Flotetuzumab for CD123-Positive Hematological Malignancies

Recruiting in Palo Alto (17 mi)

Overseen ByIbrahim Aldoss, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the best dose and side effects of flotetuzumab for the treatment of patients with blood cancers (hematological malignancies) that have spread to other places in the body (advanced) and have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Flotetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Eligibility Criteria

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.

Inclusion Criteria

Platelets >= 75,000/ul (without bone marrow involvement, performed within 14 days prior to day 1 of protocol therapy)

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

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

+44 more

Exclusion Criteria

I have had or been checked for brain involvement but am currently free of it.

I haven't had most cancer treatments in the last 2 weeks but some medications are exceptions.

I have not had major surgery or serious injury in the last 4 weeks.

+16 more

Participant Groups

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.

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.