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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2028-12-31

Brief Summary

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This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

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Detailed Description

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The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.

Conditions

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Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory MDS (Myelodysplastic Syndrome)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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phase 1 (Dose Escalation) and phase 2 (Dose Expansion)

In Phase 1, three escalating dose levels will be tested using the 3 + 3 design. The MTD and RP2D will be identified.

The Phase 2 will be conducted in 2 stages. In Stage I, evaluable participants from Phase 1 treated at RP2D will be enrolled. And the enrollment will continue into Stage II (additional evaluable participants) at the maximum RP2D participants for preliminary overall assessment of efficacy and safety.

Group Type EXPERIMENTAL

ARD103

Intervention Type BIOLOGICAL

ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion

Cyclophosphamide

Intervention Type DRUG

iv administration for lymphodepletion

Fludarabine

Intervention Type DRUG

iv administration for lymphodepletion

Interventions

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ARD103

ARD103 autologous CAR-T cell therapy targeting CLL-1, single iv. infusion

Intervention Type BIOLOGICAL

Cyclophosphamide

iv administration for lymphodepletion

Intervention Type DRUG

Fludarabine

iv administration for lymphodepletion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic status:

* Absolute lymphocyte count (ALC) \> 100/mm3
* Adequate renal, hepatic, cardiac and pulmonary function:

* ALT and AST \< 3.0 × the ULN
* Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
* Total bilirubin ≤ 2.0 mg/dL
* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
* Contraception: males and females of childbearing potential must agree to use an effective method of contraception
* Participant is capable of giving signed informed consent

Exclusion Criteria

* Participants with acute promyelocytic leukemia
* Presence of active and clinically relevant central nervous system (CNS) disorder
* Autoimmune disease requiring immunosuppressive treatment
* Participants with known hepatic bridging cirrhosis
* Currently active infection with hepatitis B or C
* Previous treatment with investigational gene or cell therapy (including CAR therapy)
* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
* Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No