BridgeMD
New treatment option for Lymphoblastic Leukemia, Acute, Childhood
Official title CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
ClinicalTrials.gov ID: NCT05043571
What this study is testing
What is CAR T-cell therapy?
CAR T-cell therapy is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for lymphoblastic leukemia, acute, childhood.
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
- 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).
- 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 6 to 65
You may be able to join 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...
- 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...
- 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
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, 6 months to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. 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.