Actively Recruiting
Anti-CD7 Protein Expression Blocker (PEBL) CAR T-Cell Therapy for Relapsed/Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)
Led by National University Hospital, Singapore · Updated on 2021-09-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating anti-CD7 CAR T-cell therapy for patients with relapsed or refractory T-lineage acute lymphoblastic leukemia (T-ALL). This phase I study aims to assess the safety and effectiveness of this novel therapy, which targets CD7, a marker present on T-ALL cells. The therapy uses anti-CD7 Protein Expression Blocker (PEBL) CAR T-cells to reduce the leukemia cell population and potentially achieve deeper remissions. Participants will receive the anti-CD7 PEBL CAR T-cell infusion in a single-arm treatment group. This approach helps prevent the T cells from attacking themselves while targeting the leukemia cells. The study includes a treatment period with infusion and follow-up assessments to monitor the persistence of CAR T-cells and disease response over time. Throughout the study, participants will undergo evaluations including flow cytometry to measure minimal residual disease (MRD) at one month post-infusion, echocardiograms to assess heart function, and other laboratory tests. Researchers will monitor safety, CAR T-cell presence in bone marrow, blood, and cerebrospinal fluid, and overall treatment response up to five years. The total study duration includes screening, treatment, and long-term follow-up.
CONDITIONS
Brief Title
CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed T-cell acute lymphoblastic leukemia or lymphoma with bone marrow, CNS, or extramedullary disease as defined by specific criteria
- Induction failure indicated by minimal residual disease (MRD) or blast levels after standard chemotherapy
- Refractory disease with MRD detected at two or more timepoints after induction therapy
- Pulmonary reserve with Grade 3 1 dyspnoea and oxygen saturation > 95% on room air
- Left ventricular systolic function (LVSF) 3 28% or left ventricular ejection fraction (LVEF) 3 45% confirmed by echocardiogram within 3 months
- Karnofsky score (age 3 16 years) or Lansky score (age < 16 years) 3 50 at screening
- Normal age-adjusted eGFR creatinine clearance within 3 months
- Alanine aminotransferase 3 5 times the upper limit of normal for age
- Blast cells with > 99% CD7 expression eligible for anti-CD7 PEBL CAR T-cell infusion
You will not qualify if you...
- Failure to meet any inclusion criteria
- Positive urine pregnancy test, pregnancy, or lactation
- Genetic syndromes with bone marrow failure except Down syndrome
- Prior malignancy except treated carcinoma in situ of skin or cervix with no active disease
- Active or latent hepatitis B or C infections 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
- Receipt of investigational medicinal product within 30 days of screening
- Uncontrolled seizures, increased intracranial pressure, or decreased consciousness from any cause in the CNS
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 anti-CD7 Protein Expression Blocker (PEBL) CAR T-cell therapy targeting relapsed or refractory T-lineage acute lymphoblastic leukemia.
1 infusion visit and multiple monitoring visits during the month following infusion
Duration - Up to 5 years
Participants are monitored for CAR T-cell persistence and disease status for up to 5 years after treatment.
Periodic visits for blood, bone marrow, and CSF sample collection
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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