CER-1236 for Acute Myeloid Leukemia

(CertainT-1 Trial)

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CER-1236, for individuals with acute myeloid leukemia (AML) who have not responded to other treatments or possess a specific genetic marker (TP53 mutation). The primary goal is to determine the safety of CER-1236 and assess its effectiveness in these patients. The trial consists of two parts, both evaluating CER-1236 alone. It seeks participants with AML or a related condition who have been struggling with their disease and have a certain level of leukemia cells in their body. As a Phase 1 trial, this research aims to understand how CER-1236 functions in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that CER-1236 is likely to be safe for humans?

Research shows that CER-1236 is still undergoing testing to determine its safety for people. This treatment is in an early study phase, focusing primarily on its safety for human use. So far, CER-1236 has been approved to continue testing, having passed initial safety checks. The FDA has granted the treatment "fast track" status, indicating a need for the treatment and early promise in its safety and effectiveness. However, more information is needed to fully understand any possible side effects or risks. As with many new treatments, the goal is to ensure it is safe and well-tolerated by patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for acute myeloid leukemia (AML), which often involve chemotherapy drugs like cytarabine or anthracyclines, CER-1236 is unique because it targets a specific molecular pathway involved in leukemia cell survival. Researchers are excited about CER-1236 as it has the potential to directly interfere with the cancer cells' growth mechanisms, possibly leading to fewer side effects compared to traditional chemotherapy. Additionally, CER-1236 is administered as a single-agent monotherapy, simplifying the treatment regimen for patients. This targeted approach might offer a more effective and patient-friendly alternative in the fight against AML.

What evidence suggests that CER-1236 might be an effective treatment for acute myeloid leukemia?

Research has shown that CER-1236 is a promising new treatment for acute myeloid leukemia (AML). This trial will evaluate CER-1236 as a single-agent therapy for patients whose AML has returned or is difficult to treat, including those with certain genetic changes. CER-1236 strengthens the immune system to better fight cancer cells. Early testing showed positive results in some patients, indicating it might help reduce the disease in the body. While more research is needed, these early findings offer hope for those seeking new treatment options. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

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

Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06834282

NCT06834282 | CER-1236 in Patients With Acute Myeloid ... 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/ ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS6581

First-in-human study of autologous chimeric engulfment ... This is an open label phase I study to evaluate the safety and preliminary activity of CER-1236 in patients with R/R AML.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/cero-first-cer1236-trial-aml/

CERo concludes first cohort of CER-1236 trial in AML CERo Therapeutics has completed the first cohort of its Phase I study of CER-1236 involving participants diagnosed with AML.

4. cero.bio cero.bio/press-release?storyId=6336586559646417

CERo Therapeutics Holdings, Inc. Doses First Patient with ... The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute ...

5. targetedonc.com targetedonc.com/view/regulatory-milestones-may-hasten-novel-immunotherapy-for-aml

Regulatory Milestones May Hasten Novel Immunotherapy ... The phase 1/1b study evaluates CER-1236's safety, efficacy, and pharmacokinetics in AML patients with significant unmet needs. ... CER-1236 in ...

6. cero.bio cero.bio/press-release?storyId=4998186183786172

CERo Therapeutics Announces Completion of First Cohort ... ... CER-1236 in AML. Study's Dose Escalation Safety Committee approves initiation ... 1236 clinical trial focused on patients with acute myeloid leukemia (AML).

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/cero-econd-cohort-aml-trial/

CERo commences second cohort of AML trial ... CER-1236 for the treatment of acute myeloid leukaemia (AML). The ... CER-1236 given the safety data and cell expansion seen to date.

8. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-cer-1236-in-acute-myeloid-leukemia

FDA Grants Fast Track Designation to CER-1236 in Acute ... CER-1236 has received fast track designation from the FDA for the treatment of patients with acute myeloid leukemia.