A Phase 1 interventional study of CD19-CAR_Lenti_ALLO in B-cell Acute Lymphoblastic Leukemia, sponsored by Bambino Gesù Hospital and Research Institute. Recruiting at 1 site in Italy. Open to participants aged 1 Year to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Bambino Gesù Hospital and Research Institute · Phase 1, Interventional, and Treatment
This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
This is a phase 1, single-center, non-randomized, open-label, dose-escalation study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of fresh, donor-derived, CD19-directed-second-generation CAR T cells (alloCART) in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL) occurring either after allogeneic hematopoietic stem cell transplantation (alloHSCT) or before alloHSCT, in case of refractory disease and availability of a HLA-fully matched donor.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's planned enrollment of 24 is below the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Bambino Gesù Hospital and Research Institute is the lead sponsor of 54 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following:
Patients Exclusion Criteria:
Concurrent or recent prior therapies, before infusion:
i. systemic steroids (at a dose of ≥ 2 mg/kg prednisone) in the 2 weeks before infusion of CD19-CAR_Lenti_ALLO cells . Recent or recurrent use of inhaled/topical/non-absorbable steroids is not exclusionary.
ii. systemic chemotherapy in the 2 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells .
iii. anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®)in the 8 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells .
iv. immuno-suppressive agentis in the 2 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells
v. radiation therapy must have been completed at least 2 weeks before infusion of CD19-CAR_Lenti_ALLO cells .
vi. other anti-neoplastic agents currently administered or within 30 days prior to infusion of CD19-CAR_Lenti_ALLO cells (i.e, start of protocol therapy).
vii. Exceptions:
Donor Eligibility Criteria
Conventional criteria for the eligibility of allogeneic donors will be adopted for the evaluation of cell donors, before apheresis, as required by law.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single IV infusion of CD19-CAR\_Lenti\_ALLO (allogeneic CD19-directed chimeric antigen receptor T-cells) on Day 0 after lymphodepletion. Patients will be divided in two cohorts based on donor HLA matching: cohort A (fully matched, familial or unrelated donor); cohort B (haploidentical donor). Patients will receive the following lymphodepletion: * Fludarabine (Flu) 30 mg/m2 per day on days -5, -4 and -3 * Cyclophosphamide (Cyclo) 1000 mg/m2 per day on days -5, -4 and -3. CD19-CAR\_Lenti\_ALLO will be infused at the following dose levels: Cohort A: * DL1: 3.0 x10\^6 CAR+ cells/kg * DL2: 5.0x10\^6 CAR+ cells/kg Cohort B: * DL1: 1x10\^6 CAR+ cells/kg * DL2: 3x10\^6 CAR + cells/kg If 2 DLT are observed in the dose level 1, an additional DL0 of 2.0x10\^6 CAR+ cells/kg (cohort A) or 0.5x10\^6 CAR+ cells/kg (cohort B) will be explored.
Drug: CD19-CAR_Lenti_ALLO
Biological/Vaccine: CD19-CAR\_Lenti\_ALLO A single infusion of CD19-CAR\_Lenti\_ALLO on Day 0
Safety and establishment of Dose limited Toxicity (DLT) of the infusion of CD19-CAR_Lenti_ALLO cells in pediatric and young adults patients affected by relapsed/refractory BCP-ALL in each dose level
DLT is defined as any of the following events: (1) Grade III-IV GvHD refractory to first and second line treatment and chronic GvHD refractory to first and second-ine treatment; (2) any grade 4 non-hematologic toxicity; (3) grade 4 reactions realted to anti-alloCART infusion; (4) death related to alloCART infusion. The Maximum Tolerated Dose/Recommended Dose (MTD/RD) of CD19-CAR\_Lenti\_ALLO to be evaluated for efficacy in the phase II extension will be defined as the highest dose level at which \<33% of patients (no more than 1 out of 6) experience DLT.
Time frame: 28 days
To estimate the rate of occurrence of acute GvHD
The occurrence of acute GvHD will be recorded for every patient
Time frame: 1 year
To estimate the severity of acute GvHD (according to the MAGIC criteria)
The severity of acute GvHD will be recorded for every patient
Time frame: 1 year
To estimate the rate of occurrence of chronic GvHD
The occurrence of chronic GvHD will be recorded for every patient
Time frame: 1 year
To estimate the severity of chronic GvHD (according to the NIH 2014 criteria)
The severity of chronic GvHD will be recorded for every patient
Time frame: 1 year
To confirm the safety of the approach at the MTD/RD dose
Toxicity of CD19-CAR\_Lenti\_ALLO cells will be recorded for every patient
Time frame: 28 days
Complete Response (CR) or Complete Response with incomplete blood count recovery (CRi) and MRD negativity achievement.
To evaluate the proportion of patients achieving CR o CR with incomplete blood count recovery (CRi) and MRD negativity by either flow-cytometry or qPCR at day 28 (defined as a value \< 1x10\^-4)
Time frame: 28 days
Probability of CR with MRD negativity achievement according to disease burden at time of enrollment.
To estimate the probability of obtaining CR with MRD negativity stratified according to the disease at time of enrollment (high disease burden being defined as \> 5% bone marrow lymphoblasts, any peripheral blood lymphoblasts, Central Nervous System (CNS) 3 status, or non-CNS Extra-Medullary (EM) site of disease.
Time frame: 28 days
To assess Overll Survival (OS) in the whole populations of patients.
Overall survival of every patient will be evaluated during follow-up
Time frame: 1 year
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bambino Gesù Hospital and Research Institute