BridgeMD
New treatment option for Acute Lymphoblastic Leukemia
Official title A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
ClinicalTrials.gov ID: NCT07066397
What this study is testing
What is ARM011?
ARM011 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people 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.
You likely can't join if
- 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)
- people 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
See the full eligibility criteria
- Male or female people 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 Key
- 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)
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.