CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
Recruiting now · Phase 1
Conditions studied: Lymphoblastic Leukemia, Acute, Childhood, Lymphoblastic Leukemia, Lymphoblastic Leukemia, Acute Adult, Lymphoblastic Leukemia in Children, CAR, CAR T-Cell-Related Encephalopathy Syndrome, Refractory Leukemia
In brief
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).
Key facts
- Study ID
- NCT05043571
- Run by
- National University Hospital, Singapore
- People needed
- 20
- Starts
- 2021-09-08
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2021-09-14
Who can join
Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis/ Disease define as:
- Relapsed T-cell acute lymphoblastic leukaemia/ lymphoma as defined by:
- Bone marrow disease = or > 0.01% by MRD as determined by flow cytometry
- Or CNS disease as defined as > 5 WBCs/ uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain
- Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites
- Induction failure as defined by:
- MRD = or > 1% by flow cytometry at the end of induction on day 33
- Or Failure to achieve morphological remission defined as > 5% blasts after standard induction chemotherapy
- Refractory disease as defined by:
- MRD = or > 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy
- Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of > 95% on room air
- Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening
- Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
- Normal Age-adjusted eGFR 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 will be eligible for anti-CD7 PEBL-CAR-T cell infusion.
You may not qualify if…
- Failure to meet any of the inclusion criteria
- Patients who test positive on urine pregnancy testing and are pregnant or are lactating
- Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
- Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening
- Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening
- Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD
- Received an investigational medicinal product within 30 days of screening
- Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure > 20 cm water; decreased conscious state (any cause)
Where it is running
- Allen Yeoh Eng Juh — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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