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New treatment option for Lymphoblastic Leukemia, Acute, Childhood
Official title ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
ClinicalTrials.gov ID: NCT05038696
What this study is testing
What is CAR T-cell therapy?
CAR T-cell therapy is an investigational medicine, 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 a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-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 80
You may be able to join if
- Fulfil the Diagnosis/ Disease define as:
- Relapsed B-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 Day 33/ End of induction: MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve...
- Refractory disease as defined by: MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy
- Any high risk features including : BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\< 45 chromosomes), p53 pathogenic...
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 BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM...
- 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 active hepatitis C within 8 weeks of screening, or any uncontrolled infection at screening
- Positive HIV test within 8 weeks of screening
See the full eligibility criteria
- Fulfil the Diagnosis/ Disease define as:
- Relapsed B-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 in CSF by morphology, or flow...
- Induction failure as defined by Day 33/ End of induction: MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve morphological remission defined as \> 5% blasts after standard induction...
- Refractory disease as defined by: MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy
- Any high risk features including : BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\< 45 chromosomes), p53 pathogenic mutation as defined by RNA Seq or other molecular methods.
- Patients who are unable to tolerate standard chemotherapy due to significant toxicity as well as other comorbidities
- Minimum level of pulmonary reserve defined as grade ≤ 1 dyspnoea and oxygen saturation of \> 95% on room air
- Left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 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 \> 99.9% of CD19 expression on blast cells will be eligible for anti-CD19 CAR T-cell infusion.
- Patients with partial or absent CD19 expression (\< 99.9%) on blast cells will be eligible to receive combinations of other CAR T-cells depending on the pattern of antigen expression.
- 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 BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM 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 active hepatitis C within 8 weeks of screening, or any uncontrolled infection at screening
- Positive 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
- Persistent disease or relapse after other forms of CAR-T cell therapy.
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 80 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.