Study Results
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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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-07-15
2041-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARM011 following lymphodepleting chemotherapy
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
ARM011
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
Fludarabine
Administered prior to infusion of ARM011
Cyclophosphamide
Administered prior to infusion of ARM011
Interventions
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ARM011
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
Fludarabine
Administered prior to infusion of ARM011
Cyclophosphamide
Administered prior to infusion of ARM011
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of ALL
3. Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
4. Disease burden: Bone marrow with evidence of disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Adequate organ functions
7. Life expectancy ≥12 weeks
Exclusion Criteria
2. Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
3. Prior anti-CD19 therapy (other than blinatumomab)
4. Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
5. autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
6. History or presence of cardiac or CNS disorders as defined in the protocol
18 Years
ALL
No
Sponsors
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TriArm Therapeutics (Taiwan) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hosein Kouros-Mehr, MD, PhD
Role: STUDY_DIRECTOR
TriArm Inc.
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIT-CD19-CAR-T-003
Identifier Type: -
Identifier Source: org_study_id
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