Actively Recruiting
A Phase I Dose Finding Study of MB-CART2219.1
Led by University Hospital Tuebingen · Updated on 2025-08-07
36
Participants Needed
2
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies
CONDITIONS
Official Title
A Phase I Dose Finding Study of MB-CART2219.1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with lymphoma aged 18 years or older
- Pediatric patients with acute lymphoblastic leukemia aged 12 years or older
- Patient or legal guardian must understand and sign informed consent
- Ability to follow study visit schedule and agree to up to 15 years of follow-up
- Malignant cells must express CD19 or CD22 as confirmed by flow cytometry or immunohistochemistry
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use effective contraception during treatment and for 12 months after
- Agreement to not donate blood during treatment and for one year after stopping treatment
- Patients must have relapsed or refractory CD19 or CD22-expressing ALL, lymphoma, or CLL meeting specific disease criteria including prior therapies and transplant eligibility
You will not qualify if you...
- Receipt of investigational agents, immunosuppressive medication, plasmapheresis, major surgery, radiation therapy (except local), or systemic anti-neoplastic or high-dose steroid therapy within 7 days before leukapheresis
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
- Clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation, or active graft versus-host disease
- History or presence of serious central nervous system conditions such as epilepsy, seizure, stroke, severe brain injuries, dementia, psychosis, or similar
- Laboratory abnormalities including low neutrophil count (<500/µL), low lymphocyte count (<200/µL), low platelet count (<50,000/mm3), poor kidney function (creatinine clearance <45 mL/min), high calcium, elevated liver enzymes, elevated bilirubin, abnormal clotting times, or recent significant bleeding
- Inadequate vascular access for leukapheresis
- Heart function with left ventricular ejection fraction less than 45%
- History of severe heart disease or recent heart attacks or arrhythmias
- Low oxygen saturation (<90%) on room air
- History of primary immunodeficiency
- Positive for HIV-1, uncontrolled hepatitis B or C, or active hepatitis A
- Ongoing infections that could jeopardize patient health
- Other malignancies not controlled for at least one year except certain noninvasive skin or cervical cancers
- Pregnancy, nursing, or intention to become pregnant during the study
- Known hypersensitivity to MB-CART2219.1 components or related drugs
- Any significant medical, laboratory, or psychiatric condition preventing participation or posing unacceptable risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital , Department of Internal Medicine II
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
2
University Hospital, Clinic for Pediatric Medicine
Tübingen, Baden-Wurttemberg, Germany, 72076
Not Yet Recruiting
Research Team
W
Wolfgang Bethge, Prof. Dr.
CONTACT
P
Peter Lang, Prof. 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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