Actively Recruiting
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
Led by Miltenyi Biomedicine GmbH · Updated on 2026-05-05
31
Participants Needed
5
Research Sites
230 weeks
Total Duration
On this page
Sponsors
M
Miltenyi Biomedicine GmbH
Lead Sponsor
P
PPD, Part of Thermo Fisher Scientific
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give age-appropriate consent or have a guardian provide consent before study procedures
- Histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm such as Burkitt lymphoma, diffuse large B-cell lymphoma, or similar aggressive B-cell lymphoma
- Relapsed or refractory B-cell neoplasms after one or more prior therapies or primary refractory to first-line therapy
- Pediatric or adolescent aged between 6 months and under 18 years
- Body weight of at least 6 kg
- Measurable disease based on pediatric NHL response criteria, with recent tissue samples available for central pathology review
- Karnofsky (age 16 and older) or Lansky (under 16) performance status of 60 or higher
- Adequate bone marrow function with specific blood count thresholds
- Adequate organ function including kidney, liver, and lung function meeting specified limits
- Female subjects of childbearing potential must agree to pregnancy testing before infusion
- Sexually active subjects must agree to use highly effective contraception methods from inclusion until 12 months post-infusion
- Willing to undergo leukapheresis to collect T cells
- Able to comply with all study procedures and assessments
You will not qualify if you...
- Currently receiving active treatment for malignant disease except pre-enrollment therapy
- History of allogeneic hematopoietic stem cell transplant
- Autologous stem cell transplant within 120 days before consent
- Major surgery within 2 weeks before leukapheresis or planned during study participation
- B-cell neoplasms related to post-transplant lymphoproliferative disorders
- Known allergy to study drug components or lymphodepleting agents
- Active central nervous system lymphoma involvement
- History or presence of autoimmune central nervous system diseases
- Infections including HIV, active or prior hepatitis B or C unless PCR negative, Treponema pallidum, COVID-19, or HTLV 1/2
- Active severe systemic infections requiring treatment
- Significant seizures or recent cerebral vascular accident
- Impaired cardiac function below specified thresholds
- Genetic syndromes causing bone marrow failure
- Pregnant or breastfeeding females
- Sexually active and unwilling to use effective contraception
- History of other malignancy within past 3 years requiring systemic therapy
- Other medical, psychological, or social conditions impacting safety or study results
- Live virus vaccination within 6 weeks before consent
- Prior treatment with approved anti-CD19 or anti-CD20 CAR-T therapies within 100 days before consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hôpital Robert Debré
Paris, Boulevard Sérurier 48, France, 75019
Active, Not Recruiting
2
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
3
Universitaetsklinikum Muenster (UKM) - Klinik fuer Kinder- und Jugendmedizin - Paediatrische Haematologie und Onkologie
Münster, Albert-Schweitzer-Campus 1, Gebaeude A1, Germany, 48129
Active, Not Recruiting
4
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Piazza Sant Onofrio 4, Italy, 00165
Actively Recruiting
5
Prinses Maxima Centrum
Utrecht, Heidelberglaan 25, Netherlands
Active, Not Recruiting
Research Team
A
Andrey Shirokov
CONTACT
G
Gregor Zadoyan, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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