Acute Lymphoblastic LeukemiaPhase 1NCT07066397
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
A Phase 1 study testing ARM011, Fludarabine and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, run by TriArm Therapeutics (Taiwan) Limited at 1 site in Taiwan.
Trial summary
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- ARM011, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2025to 1 Apr 2041
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age ≥18 years
- Diagnosis of ALL
- Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
- Disease burden: Bone marrow with evidence of disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate organ functions
- Life expectancy ≥12 weeks
Who cannot join
- Active central nervous system (CNS) involvement of ALL
- Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- Prior anti-CD19 therapy (other than blinatumomab)
- Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
- autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
- History or presence of cardiac or CNS disorders as defined in the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Shangju Wu, +886 0972-652-039, wushangju@ntu.edu.tw
Shangju Wu
About this study
Official title: A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 Chimeric Antigen Receptor T Cells (FIT-CD19-CAR-T Cells) Infusion for Subjects With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Read the detailed description
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- ARM011, Fludarabine, Cyclophosphamide
- Keywords
- CAR T-Cell Therapy, Acute lymphoblastic leukemia, CD19, non-viral, fast CAR
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM011Biological
ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process
FludarabineDrug
Administered prior to infusion of ARM011
CyclophosphamideDrug
Administered prior to infusion of ARM011
| Study group | Role | What they receive |
|---|---|---|
| ARM011 following lymphodepleting chemotherapy | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011 Receives: Biological: ARM011; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events [Safety and Tolerability]
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Measured: Up to 24 months after ARM011 infusion
Secondary outcomes (5)
Evaluate cellular kinetics and persistence of ARM011
Cellular kinetics related peak (Cmax) in peripheral blood
Measured: Up to 24 months after ARM011 infusion
Evaluate cellular kinetics and persistence of ARM011
Area under the concentration time curve (AUC) in peripheral blood
Measured: Up to 24 months after ARM011 infusion
Evaluate preliminary anti-tumor activity of ARM011
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including complete response or complete remission with incomplete count recovery)
Measured: Up to 24 months after ARM011 infusion
Evaluate host immunogenicity to ARM011
Incidence of anti-CD19-directed CAR antibodies
Measured: Up to 24 months after ARM011 infusion
Evaluate the feasibility of administration of ARM011
The proportion of subjects for whom a CAR T-cell product meeting specifications could be prepared, which will be computed with a corresponding 95% confidence interval (CI).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Jul 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriArm Therapeutics (Taiwan) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hosein Kouros-Mehr, MD, PhD, Study director, TriArm Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066397
- Sponsor's protocol ID
- FIT-CD19-CAR-T-003
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 Chimeric Antigen Receptor T Cells (FIT-CD19-CAR-T Cells) Infusion for Subjects With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07066397
- Acronym / sponsor ID
- FIT-CD19-CAR-T-003
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- CAR T-Cell Therapy, Acute lymphoblastic leukemia, CD19, non-viral, fast CAR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- TriArm Therapeutics (Taiwan) LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2041 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Detailed description
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM011 following lymphodepleting chemotherapy | Experimental | Biological: ARM011, Drug: Fludarabine, Drug: CyclophosphamideA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects age ≥18 years
- Diagnosis of ALL
- Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
- Disease burden: Bone marrow with evidence of disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (6 listed)
- Active central nervous system (CNS) involvement of ALL
- Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- Prior anti-CD19 therapy (other than blinatumomab)
- Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
- autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARM011ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process | Biological | ARM011 following lymphodepleting chemotherapy |
| FludarabineAdministered prior to infusion of ARM011 | Drug | ARM011 following lymphodepleting chemotherapy |
| CyclophosphamideAdministered prior to infusion of ARM011 | Drug | ARM011 following lymphodepleting chemotherapy |
Primary outcome
Incidence of adverse events [Safety and Tolerability]
Time frame: Up to 24 months after ARM011 infusion
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
5 secondary outcomes
Evaluate cellular kinetics and persistence of ARM011
Time frame: Up to 24 months after ARM011 infusion
Evaluate cellular kinetics and persistence of ARM011
Time frame: Up to 24 months after ARM011 infusion
Evaluate preliminary anti-tumor activity of ARM011
Time frame: Up to 24 months after ARM011 infusion
Evaluate host immunogenicity to ARM011
Time frame: Up to 24 months after ARM011 infusion
Evaluate the feasibility of administration of ARM011
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hosein Kouros-Mehr, MD, PhD study director
TriArm Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARM011, Fludarabine and Cyclophosphamide in people with Acute Lymphoblastic Leukemia, run by TriArm Therapeutics (Taiwan) Limited at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reta Ruan (+86 13641883361, reta@triarm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events [Safety and Tolerability] (time frame: Up to 24 months after ARM011 infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.