GO-203-2C for Acute Myeloid Leukemia

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Investigational agents, Anti-leukemic therapy

Disqualifiers: Leukemic meningitis, Uncontrolled hypertension, Cardiac disease, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a targeted therapy known as GO-203-2C as a possible treatment for with acute myeloid leukemia (AML) both alone and in combination with decitabine. GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.

Will I have to stop taking my current medications?

The trial requires that you stop any other anti-leukemic therapy (except hydroxyurea) at least 2 weeks before starting the study treatment. The protocol does not specify about other medications, so it's best to discuss with the study team.

What data supports the effectiveness of the drug GO-203-2C for Acute Myeloid Leukemia?

The drug gemtuzumab ozogamicin (GO), which targets a protein called CD33 on leukemia cells, has shown improved outcomes in patients with Acute Myeloid Leukemia (AML) when used in combination with other treatments. It has been re-approved based on new data showing its effectiveness, especially in patients with certain genetic markers. ^{1 2 3 4 5}

How is the drug GO-203-2C different from other treatments for acute myeloid leukemia?

GO-203-2C is unique because it targets CD33, a protein found on leukemia cells, similar to gemtuzumab ozogamicin (GO), but it may offer a different mechanism or improved safety profile compared to existing CD33-targeted therapies. ^{2 4 6 7 8}

Research Team

David Avigan, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that's come back or didn't respond to initial treatment. They should be in decent health otherwise, not pregnant, and willing to use birth control. People with severe heart issues, active infections, recent major surgery, or HIV can't join.

Inclusion Criteria

corrected calcium level ≥ institutional LLN

Negative pregnancy test in women of child-bearing potential

serum bilirubin ≤ 1.5 X institutional ULN OR serum direct bilirubin ≤ 2 X institutional ULN

Exclusion Criteria

Unwilling or unable to comply with the requirements of the study protocol

Uncontrolled or poorly controlled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg) Note: an isolated reading that is not sustained will be permitted.

Evidence of NYHA Class III or IV cardiac disease, or presence of unstable life-threatening arrhythmia, or history of myocardial infarction during the past 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Determination of the maximum tolerated dose (MTD) of GO-203-2c, with dose escalation using a 3+3 approach

28 days

Daily visits for drug administration

Phase II Treatment

Evaluation of clinical response to the combination of GO-203-2c and decitabine

2 years

28-day treatment cycles with decitabine administered on days 8-12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Decitabine
• GO-203-2c

Trial Overview The study tests GO-203-2C alone and combined with Decitabine as treatments for AML. It aims to find the safest dose of GO-203-2C and see how well it works against leukemia cells without harming normal cells.

Participant Groups

Group I: GO-203-2c + Decitabine Experimental Treatment 2 Interventions

Dose escalation will occur for GO-203-2c using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle. Decitabine will be administered at a dose of 20mg/m2 on days 8-12 of a 28-day treatment cycle.

Group II: GO-203-2c Experimental Treatment 1 Intervention

Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. GO-203-2c given daily on predetermined schedule of a 28-day treatment cycle

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Gemtuzumab ozogamicin and novel antibody-drug conjugates in clinical trials for acute myeloid leukemia. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

CD33 Expression and Gentuzumab Ozogamicin in Acute Myeloid Leukemia: Two Sides of the Same Coin. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Biomarkers of Gemtuzumab Ozogamicin Response for Acute Myeloid Leukemia Treatment. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Investigational CD33-targeted therapeutics for acute myeloid leukemia. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Treating CD33-Positive de novo Acute Myeloid Leukemia in Pediatric Patients: Focus on the Clinical Value of Gemtuzumab Ozogamicin. [2023]

6. England pubmed.ncbi.nlm.nih.gov

CD33/CD3-bispecific T-cell engaging (BiTE®) antibody construct targets monocytic AML myeloid-derived suppressor cells. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Gemtuzumab ozogamicin in acute myeloid leukemia. [2019]

8. Singapore pubmed.ncbi.nlm.nih.gov

Antibody-based therapy of acute myeloid leukemia with gemtuzumab ozogamicin. [2022]