BridgeMD
Tests treatment safety and results for B-Cell Neoplasm
Official title Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
ClinicalTrials.gov ID: NCT06508931
What this study is testing
What is zamtocabtagene autoleucel (MB-CART2019.1)?
zamtocabtagene autoleucel (MB-CART2019.1) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell neoplasm.
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
- This is a single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric and adolescent subjects (aged between 6 months and \<18 years, ≥6 kg body weight [BW]) with mature B-cell neoplasms and aggressive lymphomas that relapsed after or are refractory to one or more prior therapies, including subjects with primary refractory disease.
- Phase 2: a mid-size study of how well it works
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 17
You may be able to join if
- Is able to provide age-appropriate assent/consent (as applicable, according to local legislation) and/or have a guardian able to provide consent...
- Has histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm such as:
- Burkitt lymphoma/Burkitt leukemia
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- Primary mediastinal (thymic) large B-cell lymphoma
You likely can't join if
- Is receiving active treatment for malignant disease (including participation in any additional parallel investigational drug or device studies)...
- Had allogeneic HSCT.
- Had autologous HSCT \<120 days prior to written informed consent.
- Had major surgery within 2 weeks before leukapheresis, or has not fully recovered from an earlier surgery, or has major surgery planned during the...
- people with B-cell neoplasms in the context of post-transplant lymphoproliferative disorders-associated lymphomas.
- Has known hypersensitivity to the excipients of the MB-CART2019.1 or to any other drug product as advised for administration in the study protocol...
See the full eligibility criteria
Who can join
- Is able to provide age-appropriate assent/consent (as applicable, according to local legislation) and/or have a guardian able to provide consent signed and dated by the parent(s) or by subject's legal guardian before...
- Has histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm such as:
- Burkitt lymphoma/Burkitt leukemia
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- Primary mediastinal (thymic) large B-cell lymphoma
- Burkitt-like lymphoma with 11q aberration
- Aggressive mature B-cell lymphoma
- Other rare aggressive B-cell non-Hodgkin lymphoma (NHL) after sponsor approval.
- Has r/r B-cell neoplasms after one or more prior therapies or primary refractory to first-line therapy.
- Is a pediatric/adolescent (aged between 6 months and \<18 years).
- Has a BW of ≥ 6 kg.
- Measurable disease based on the International Pediatric NHL Response Criteria (which refers to the Lugano criteria for definitions of measurability and selecting index lesions), as identified by local radiological...
- Tissue samples archival or fresh (preferred) from recent relapse or initial diagnosis (in case of primary refractory disease) must be made available for the central pathology review to confirm diagnosis (≤2 years...
- Has Karnofsky (aged ≥16 years) or Lansky (aged \<16 years) performance status ≥60.
- Has adequate bone marrow function as defined by the following laboratory values (as assessed by local laboratory for eligibility):
- Absolute neutrophil count (ANC) \>1000/μL.
- Platelets ≥50000/μL.
- Hemoglobin ≥8.0 g/dL.
- Absolute lymphocyte count ≥100/μL.
- Has adequate organ function as follows:
- Renal function: estimated glomerular filtration rate (eGFR) \>29 mL/min by Schwartz formula (Schwartz et al 1976).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × upper limit of normal (ULN) for age.
- Bilirubin \<1.5 x ULN (for Gilbert's Syndrome, subject's total bilirubin \<4 mg/dL).
- Adequate pulmonary function as follows:
- Resting oxygen saturation of ≥91% on room air.
- No or mild dyspnea (Grade ≤1).
- Female people of childbearing potential must be willing to undergo pregnancy tests before MB-CART2019.1 infusion.
- If people are sexually active, they must be willing to use highly effective methods of contraception.
- Female people must agree to use two methods of contraception;
- one of the following methods (Pearl index \<1%): Hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, injected, implanted, transdermal), intrauterine devices (IUDs) or systems (e.g...
- Highly effective methods of contraception must be followed from inclusion until 12 months after MB-CART2019.1 infusion.
- Male people must agree to use a condom during intercourse from inclusion through at least 12 months after MB-CART2019.1 infusion to prevent them from fathering a child AND to prevent delivery of MB-CART2019.1 via...
- Females must agree not to breast feed or donate eggs/ova during the study and until at least 12 months after MB-CART2019.1 infusion.
- Is willing to undergo collection of non-mobilized leukapheresis.
- In the opinion of the investigator, the subject must be able to comply with all study-related procedures, medication use, and assessments.
What rules you out
- Is receiving active treatment for malignant disease (including participation in any additional parallel investigational drug or device studies), except for pre-enrollment therapy, including radiotherapy. Lesions that...
- Had allogeneic HSCT.
- Had autologous HSCT \<120 days prior to written informed consent.
- Had major surgery within 2 weeks before leukapheresis, or has not fully recovered from an earlier surgery, or has major surgery planned during the time the subject is expected to participate in the study.
- people with B-cell neoplasms in the context of post-transplant lymphoproliferative disorders-associated lymphomas.
- Has known hypersensitivity to the excipients of the MB-CART2019.1 or to any other drug product as advised for administration in the study protocol (e.g., lymphodepleting agents).
- Has active central nervous system (CNS) involvement at the time point of eligibility confirmation, as measured by the presence of lymphoma cells in cerebral spinal fluid (CSF) on cytospin preparation.
- Has history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory diseases.
- Infection with human immunodeficiency virus (HIV).
- Presence of active or prior hepatitis B or C as indicated by serology. Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction (PCR) negative.
- Has infection with Treponema pallidum.
- Has active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Has infection with human T-lymphotropic virus 1/2 (HTLV 1/2).
- Has active severe systemic fungal, viral, or bacterial infection, requiring systemic antiviral, antifungal, or antimicrobial therapy.
- Has clinically significant seizures according to the opinion of by the investigator.
- Has history of cerebral vascular accident within 12 months prior to leukapheresis.
- Has impaired cardiac function: Fractional shortening \<28% or left ventricular ejection fraction \<50% by echocardiography or multigated acquisition, if allowed as per local law.
- Has concomitant genetic syndromes associated with bone marrow (BM) failure status, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known BM failure syndrome.
- Is a pregnant or breast-feeding female.
- Is sexually active and not willing to use highly effective methods of contraception as described in the inclusion criteria.
- Has history of another malignancy within the prior 3 years that required systemic therapy.
- Has other medical, psychological, or social condition that, in the opinion of the investigator, would impact subject safety or confound the study results.
- Has received vaccination with live virus within 6 weeks prior to informed consent.
- Has been previously treated with approved anti-CD19 or anti-CD20 CART cell therapies \<100 days prior to informed consent/assent.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Boulevard Sérurier 48, France
- Villejuif, France
- Münster, Albert-Schweitzer-Campus 1, Gebaeude A1, Germany
- Rome, Piazza Sant Onofrio 4, Italy
- Utrecht, Heidelberglaan 25, Netherlands
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 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Boulevard Sérurier 48, France; Villejuif, France; Münster, Albert-Schweitzer-Campus 1, Gebaeude A1, Germany; Rome, Piazza Sant Onofrio 4, Italy; Utrecht, Heidelberglaan 25, Netherlands. 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.