Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06680752

Phase 12 Study of ARD103 CAR-T Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Q: What is ARD103 studying for relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome?

ARD103 is being studied as a CAR-T cell therapy targeting leukemia cells in patients with relapsed or refractory AML or MDS. Researchers aim to understand its safety and ability to produce a response in these blood cancers. The trial is sponsored by ARCE Therapeutics, Inc. to explore new treatment options for these conditions.

Q: Who may be eligible for this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Adults aged 18 years or older with relapsed or refractory AML or MDS having at least 5% bone marrow blasts may be eligible. Participants should have a good performance status and adequate organ function. Both males and females can join. Please review eligibility criteria for more details.

Q: Is there any cost to participate in this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel-related costs.

Led by ARCE Therapeutics, Inc. · Updated on 2025-12-10

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ARD103, an investigational CAR-T cell therapy targeting CLL-1, in patients with relapsed or refractory acute myeloid leukemia AML or myelodysplastic syndrome MDS. This phase 12, open-label, multicenter study aims to assess the safety and effectiveness of ARD103. CLL-1 is a molecule found on leukemia cells but not on normal blood stem cells, making it a promising target for treatment in these blood cancers. The study includes a phase 1 dose escalation part where three increasing dose levels of ARD103 will be tested to find the maximum tolerated dose and recommended phase 2 dose. Phase 2 has two stages the first involves patients from phase 1 treated at the recommended dose, and the second enrolls additional patients to further evaluate safety and overall response. ARD103 is given as a single intravenous infusion after patients receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine. Participants will be monitored for treatment-related side effects for 28 days after infusion and followed for up to 24 months to measure overall response rate, progression-free survival, and time to best response. Survival will be observed up to 15 years. Assessments include blood tests, physical exams, and other evaluations to track safety and effectiveness. The total duration of participation varies with long-term follow-up planned to understand outcomes and safety over time.

CONDITIONS

Brief Title

Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Investigational ARD103 CAR‑T therapy	Current standard salvage treatment (e.g., transplant or chemotherapy)
What it is	An early‑phase investigational autologous CAR‑T cell therapy engineered to target CLL‑1 after lymphodepleting chemotherapy	Existing salvage strategies for r/r AML or MDS include hematopoietic stem cell transplant or intensive salvage chemotherapy depending on patient fitness and prior treatments
Role in the trial	Participants receive ARD103 following lymphodepletion to evaluate safety, dosing, and response	Not used in this study but represents what patients might otherwise receive outside the trial
Primary use	Evaluate safety, tolerability, recommended phase 2 dose, and response rate in r/r AML or MDS	To achieve disease remission or disease control as salvage therapy in relapsed/refractory AML or MDS
How it is given or done	Single autologous intravenous infusion of ARD103 following preparative chemotherapy with cyclophosphamide and fludarabine	Hematopoietic stem cell transplant involves high‑intensity conditioning and infusion; salvage chemotherapy uses multi‑agent regimens
Evidence status	Safety and effectiveness under evaluation; no results yet published	Salvage treatments have achieved remissions in selected r/r patients but outcomes remain generally poor
Important limitations	Early‑phase study with limited patient number and no direct comparator arm	Not all r/r patients are eligible for transplant and salvage chemotherapy often has modest durability of response

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS with at least 5% bone marrow blasts
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute lymphocyte count greater than 100/mm3
Adequate liver function with ALT and AST less than 3 times the upper limit of normal
Adequate kidney function with creatinine clearance at least 45 mL/min as estimated by Cockcroft-Gault and no dialysis
Total bilirubin less than or equal to 2.0 mg/dL
Negative pregnancy test for females of childbearing potential
Agreement to use effective contraception for males and females of childbearing potential
Ability to give signed informed consent

You will not qualify if you...

Diagnosis of acute promyelocytic leukemia
Active and clinically relevant central nervous system disorder
Autoimmune disease requiring immunosuppressive treatment
Known hepatic bridging cirrhosis
Active infection with hepatitis B or C
Previous treatment with investigational gene or cell therapy including CAR therapy
Active acute graft-versus-host disease or systemic treatment with more than 10 mg prednisone daily (or equivalent)
Chemotherapy including biologic, targeted, or immunological agents within 14 days prior to screening and during the study

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 days post ARD103 infusion

Participants receive lymphodepletion with cyclophosphamide and fludarabine followed by a single intravenous infusion of ARD103 CAR-T cell therapy targeting CLL-1.

Multiple visits during the treatment period including infusion and monitoring

Follow-up

Duration - Up to 24 months for response and progression-free survival; up to 15 years for overall survival

Participants are monitored for safety, efficacy, and long-term outcomes after treatment.

Regular follow-up visits over the monitoring period

Research Team

ARCE Therapeutics, Inc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

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Frequently Asked Questions

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Phase 12 Study of ARD103 CAR-T Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Phase IIb Study of BP1002 Liposomal Bcl-2 Antisense Drug for...

Phase 1 Study of CG009301 Injection for Adults with Relapsed...

Study of Cyclophosphamide-Based Treatment to Prevent Graft-V...

Frequently Asked Questions

What is ARD103 studying for relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome?

Who may be eligible for this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Is there any cost to participate in this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Will I receive ARD103 or a placebo?

How will the study measure treatment effects for AML or MDS?

What happens after this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial ends?

Can I leave this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial if I change my mind?

Not the Right Trial for You?

On this page

Sponsors

Sponsors

How This Trial Compares With Other Options

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Phase IIb Study of BP1002 Liposomal Bcl-2 Antisense Drug for...

Phase 1 Study of CG009301 Injection for Adults with Relapsed...

Study of Cyclophosphamide-Based Treatment to Prevent Graft-V...

Frequently Asked Questions

What is ARD103 studying for relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome?

Who may be eligible for this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Is there any cost to participate in this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial?

Will I receive ARD103 or a placebo?

How will the study measure treatment effects for AML or MDS?

What happens after this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial ends?

Can I leave this relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome clinical trial if I change my mind?

Sponsors