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New treatment option for Acute Lymphoblastic Leukemia
Official title MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07371403
What this study is testing
What is MB-CART19.1?
MB-CART19.1 is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia.
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
- Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- Age ≥ 1 year as long as if deemed fit by treating investigator
- CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
- Patients with relapsed or refractory disease with \>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen...
- Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking...
- Estimated life expectancy \> 12 weeks
You likely can't join if
- Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
- Persistent extramedullary disease.
- Isolated CNS and/or testicular disease.
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active hepatitis B, C or HIV
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage...
See the full eligibility criteria
- Age ≥ 1 year as long as if deemed fit by treating investigator
- CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.
- Patients with relapsed or refractory disease with \>5% blasts in the bone marrow after at least one frontline and one salvage chemotherapy regimen. For patients with Philadelphia-positive disease, a second generation or...
- Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
- Estimated life expectancy \> 12 weeks
- Karnofsky or Lansky (age dependent) performance score ≥ 60
- Patients and/or parents must give their written informed consent/assent.
- CNS and/or testicular involvement are allowed, only if cleared and in the presence of systemic involvement.
- Rapidly progressive, uncontrolled disease as assessed by the treating physician and/or principal investigator.
- Persistent extramedullary disease.
- Isolated CNS and/or testicular disease.
- Current autoimmune disease, or history of autoimmune disease with potential CNS involvement
- Active hepatitis B, C or HIV
- Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
- History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.
- Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \ 28% O2 FiO2 or active pulmonary infection.
- Cardiac function: Left ventricular ejection fraction \<50% by echocardiography
- Renal function: Creatinine clearance \<50 mL/min/1.73 m2
- Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.
- Pregnant or breast-feeding females
- Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\<0.5 mg/kg/day of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis...
The study team makes the final eligibility decision.
Where it's taking place
- Amman, Jordan
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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amman, Jordan. 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.