Actively Recruiting
Chimeric-Antigen Receptor (CAR) T-Cell Therapy Using Multiple CARs and Cell Marker Profiling in High Risk and Relapsed/Refractory B-Lineage Acute Lymphoblastic Leukemia
Led by National University Hospital, Singapore · Updated on 2021-09-09
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a personalized CAR T-cell therapy approach for patients with high-risk, refractory, or relapsed B-lineage acute lymphoblastic leukemia (B-ALL). This study aims to tailor the treatment to the unique leukemic cell profile of each patient to target the entire leukemia population and potentially achieve deeper, longer-lasting remissions. The trial is a Phase I study focusing on optimizing treatment dose to balance effectiveness and minimize toxicity while considering cost constraints. Participants will receive CAR T-cells designed to target specific markers on their leukemia cells, based on detailed profiling of each patient's disease. This individualized treatment approach avoids giving all patients the same broad CAR T-cell dose, which could increase toxicity and cost. The study is a single-arm trial where all patients receive this customized CAR T-cell therapy. The dosing is carefully determined to reduce treatment failure risk while limiting exposure to excessive CAR T-cell amounts. During the study, participants will be closely monitored with tests such as flow cytometry to measure minimal residual disease (MRD) one month after infusion, along with assessments of CAR T-cell persistence and B-cell aplasia up to five years. Researchers will perform blood, bone marrow, and cerebrospinal fluid analyses to evaluate treatment response and safety. The trial includes detailed evaluations of heart and lung function and performance status before treatment to ensure participant safety. Overall participation duration extends over several years to observe long-term effects and outcomes.
CONDITIONS
Brief Title
ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed B-cell acute lymphoblastic leukemia/lymphoma with bone marrow disease ≥ 0.01% by MRD or CNS disease or extramedullary relapse
- Induction failure defined by MRD ≥ 1% by flow cytometry or > 5% blasts after induction chemotherapy
- Refractory disease with MRD ≥ 0.01% at two or more timepoints after induction
- High-risk features including BCR-ABL1, BCR-ABL1-like, ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL, or p53 pathogenic mutation
- Unable to tolerate standard chemotherapy due to toxicity or comorbidities
- Pulmonary reserve with grade ≤ 1 dyspnoea and oxygen saturation > 95% on room air
- Left ventricular systolic function ≥ 28% or ejection fraction ≥ 45% by echocardiogram within 3 months
- Karnofsky (≥ 16 years) or Lansky (< 16 years) performance status ≥ 50
- Normal age-adjusted eGFR creatinine clearance within 3 months
- Alanine aminotransferase ≤ 5 times the upper limit of normal
- CD19 expression on blast cells > 99.9% for anti-CD19 CAR T-cell infusion
- Partial or absent CD19 expression (< 99.9%) eligible for other CAR T-cell combinations based on antigen pattern
You will not qualify if you...
- Failure to meet inclusion criteria
- Positive urine pregnancy test, pregnancy, or lactation
- Genetic syndromes with bone marrow failure (except Down syndrome)
- Prior malignancy except certain treated skin or cervical carcinoma in situ without active disease
- Active or latent hepatitis B, active hepatitis C within 8 weeks, or uncontrolled infection
- Positive HIV test within 8 weeks
- Grade 2 to 4 acute graft-versus-host disease or extensive chronic GVHD
- Received investigational medicinal product within 30 days
- Persistent disease or relapse after other CAR T-cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive CAR T-cell therapy tailored to their leukemia cell profile to induce remission.
1 baseline visit and multiple visits during the first month after infusion
Duration - Up to 5 years
Participants are monitored for CAR T-cell persistence, disease status, and safety outcomes for up to 5 years after treatment.
Multiple visits at scheduled time points over 5 years
Trial Site Locations
Total: 1 location
1
Allen Yeoh Eng Juh
Singapore, Singapore, 119228
Actively Recruiting
Research Team
A
Allen Yeoh, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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