Actively Recruiting
A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies
Led by University Hospital Tuebingen · Updated on 2025-08-07
36
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I dose finding study to evaluate MB-CART2219.1, a CAR-T cell therapy targeting CD19 and CD22, in adults and children aged 12 to 75 years with relapsed or refractory B-cell malignancies, including lymphoma, chronic lymphocytic leukemia, and pediatric acute lymphoblastic leukemia. This early phase study aims to find a safe and feasible dose for this biological treatment using a 3+3 design. Participants receive CAR-T cells at different dose levels ranging from 0.25 to 2 million CAR-transduced T cells per kilogram of body weight to determine the best dose. The study evaluates safety and feasibility over six months, focusing on adverse events graded by CTCAE criteria. This dose finding is essential before further testing of treatment effectiveness. During the study, participants undergo regular visits for monitoring, including assessments of their disease and treatment side effects. Researchers track safety outcomes and feasibility over six months and require participants to commit to follow-up visits for up to 15 years to monitor long-term effects as part of gene therapy guidelines. Blood tests and other clinical evaluations will be done to assess response and side effects.
CONDITIONS
Brief 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 at consent
- Pediatric patients with acute lymphoblastic leukemia aged 12 years or older at consent
- Patient or legal guardian must understand and voluntarily sign informed consent
- Able to follow study visit schedule and agree to follow-up for up to 15 years
- Malignant cells must express CD19 or CD22 as detected by lab tests
- Female participants of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 12 months after
- Agreement to avoid blood donation during treatment and for 1 year after
- Patients must have relapsed or refractory CD19 or CD22-expressing ALL or lymphoma/CLL meeting disease-specific criteria including prior treatments and transplant status
You will not qualify if you...
- Receipt of investigational agents, immunosuppressive medication, plasmapheresis, major surgery, or systemic anti-cancer drugs within 7 days before leukapheresis
- ECOG performance status greater than 3 at screening
- Clinical signs of lung leukostasis, blood clotting disorders, or active graft versus-host disease
- History of serious brain or nervous system conditions such as seizures, stroke, severe injury, dementia, or psychosis
- Lab abnormalities including low neutrophils, lymphocytes, platelets, kidney function, calcium, liver enzymes, bilirubin, or blood clotting parameters
- Inadequate vascular access for leukapheresis
- Reduced heart function or recent serious heart conditions
- Poor lung function with oxygen saturation below 90% on room air
- History of primary immune deficiency
- Positive tests for HIV, uncontrolled hepatitis B or C, or active hepatitis A
- Ongoing infections that could risk patient health
- Other cancers unless controlled for at least 1 year, except some skin and cervical cancers
- Pregnancy, breastfeeding, or intention to become pregnant during study
- Known allergy to study treatment components or related drugs
- Any medical, lab, or psychiatric condition that prevents study participation or risks patient safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive CAR-T cells targeting CD19 and CD22 to treat relapsed or refractory B-cell malignancies. Dose levels will be assessed using a 3+3 design.
Multiple visits as part of dose escalation and monitoring
Duration - Up to 15 years
Participants are monitored for safety, feasibility, and long-term outcomes after treatment.
Regular follow-up visits over several years
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.
P
Peter Lang, Prof. Dr.
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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