Actively Recruiting
CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
Led by National University Hospital, Singapore · Updated on 2021-09-14
20
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).
CONDITIONS
Official 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 defined by bone marrow disease (≥ 0.01% by MRD flow cytometry), CNS disease (> 5 WBCs/µL in CSF with blasts), or extramedullary relapse with blasts
- Induction failure defined by MRD ≥ 1% by flow cytometry at end of induction (day 33) or > 5% blasts after standard induction chemotherapy
- Refractory disease defined by MRD ≥ 0.01% by flow cytometry or molecular methods at two or more timepoints after induction
- Pulmonary reserve with grade ≤ 1 dyspnea and oxygen saturation > 95% on room air
- Left ventricular systolic function ≥ 28% or ejection fraction ≥ 45% by echocardiogram within 3 months of screening
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
- Normal age-adjusted creatinine clearance within 3 months of screening
- Alanine aminotransferase ≤ 5 times the upper limit of normal for age
- Patients with > 99% CD7 expression on blast cells 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 or pregnant or lactating
- Genetic syndromes causing bone marrow failure except Down syndrome (e.g., Fanconi anaemia, Kostmann syndrome, Schwachman 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 of screening or any uncontrolled infection
- Positive HIV test within 8 weeks of screening
- Grade 2 to 4 acute graft-vs-host disease or extensive chronic GVHD
- Received investigational medicinal product within 30 days of screening
- Central nervous system conditions: uncontrolled seizures or status epilepticus; increased intracranial pressure; decreased consciousness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Allen Yeoh Eng Juh
Singapore, Singapore, 119228
Actively Recruiting
Research Team
A
Allen Yeoh, M.D
CONTACT
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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