CER-1236 for Acute Myeloid Leukemia

(CertainT-1 Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: CERo Therapeutics Holdings, Inc.

Disqualifiers: Autoimmune disease, Immunodeficiency, others

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

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug CER-1236 for treating acute myeloid leukemia?

The research mentions CC-486, an oral form of azacitidine, showing promising results in older patients with AML, and CPX-351, a combination of cytarabine and daunorubicin, improving survival in high-risk AML cases. These findings suggest that similar treatments to CER-1236 may have potential effectiveness in AML. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with Acute Myeloid Leukemia (AML) who have relapsed or are not responding to treatment, and those with a specific genetic change called TP53mut. Participants should be in good physical condition (ECOG 0-1), have a confirmed AML diagnosis, and an adequate number of lymphocytes.

Inclusion Criteria

Absolute lymphocyte count >0.3 x 10^9/L prior to apheresis

I have been diagnosed with AML or MDS/AML with 10-19% blasts.

I am fully active or can carry out light work.

Exclusion Criteria

I have had treatment with genetically modified cells before.

I have an autoimmune disease but it's either inactive, or I haven't needed treatment for it in the last 2 years, except for thyroid issues or type 1 diabetes which are under control.

A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Escalation Phase

The primary objectives are to define the safety of different doses of CER-1236 and to define the recommended dose for the Expansion Phase

28 days

Multiple visits for dose escalation and monitoring

Expansion Phase

Evaluate the safety and efficacy of CER-1236 in patients with acute myeloid leukemia

2 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CER-1236

Trial Overview The study tests CER-1236's safety and effectiveness in patients with hard-to-treat AML. It's given alongside standard drugs Cyclophosphamide, Fludarabine, and Mesna. This early-phase trial will gradually increase doses to find the safest amount that works.

Participant Groups

Group I: Part 2: Single Agent CER-1236 Experimental Treatment 4 Interventions

AML patient treated with a single dose of CER-1236 monotherapy

Group II: Part 1: Single Agent CER-1236 Experimental Treatment 4 Interventions

AML patient treated with a single dose of CER-1236 monotherapy

Who Is Running the Clinical Trial?

CERo Therapeutics Holdings, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

The QUAZAR AML Maintenance trial is a Phase III study investigating the efficacy of CC-486, an oral formulation of azacitidine, in prolonging overall survival for older patients (aged ≥55) with acute myeloid leukemia (AML) in first complete remission.

The trial will assess not only overall survival but also relapse-free survival, safety, and quality of life, aiming to determine if CC-486 can improve outcomes for this patient population compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Roboz, GJ., Montesinos, P., Selleslag, D., et al.[2018]

In a study of 353 adults with acute myeloid leukemia (AML) treated with CPX-351, younger patients (<60 years) had a median overall survival (OS) of 17.3 months, compared to 11.7 months for older patients (≥60 years), indicating that CPX-351 is effective across different age groups.

The study found a low all-cause mortality rate of 6% overall within 30 days of diagnosis, suggesting that CPX-351 is a safe treatment option, with a significant proportion of younger patients (54%) receiving hematopoietic cell transplantation after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience With CPX-351 Treatment for Acute Myeloid Leukemia in England: An Analysis From the National Cancer Registration and Analysis Service. Legg, A., Lambova, A., Broe, A., et al.[2023]

The standard treatment for acute myeloid leukemia (AML), known as '3 + 7' (daunorubicin and cytarabine), has not changed in 44 years and remains the primary induction regimen, but it has a high relapse rate and often leads to resistance in patients.

Genetic risk stratification is crucial for identifying patients who may not respond well to '3 + 7', suggesting that these patients should be considered for clinical trials to explore newer, more effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytarabine and daunorubicin for the treatment of acute myeloid leukemia. Murphy, T., Yee, KWL.[2018]

References

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

Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Real-World Experience With CPX-351 Treatment for Acute Myeloid Leukemia in England: An Analysis From the National Cancer Registration and Analysis Service. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cytarabine and daunorubicin for the treatment of acute myeloid leukemia. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Investigational Agents and Pathways That May Influence the Future Management of Acute Myeloid Leukemia. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Challenges in the diagnosis and treatment of secondary acute myeloid leukemia. [2019]