LymphomaPhase 1NCT07108868
A Phase I Dose Finding Study of MB-CART2219.1
A Phase 1 study testing CAR-T cells targeting CD19 and CD22 in people with Lymphoma and CLL, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Lymphoma, CLL, Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- CAR-T cells targeting CD19 and CD22
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Jun 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- For Cohort II ALL, pediatric patients: Subject is ≥ 12-17 years of age at the time of signing ICF.
- Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.
- CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.
- Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.
Show all 44Show fewer
- All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.
- Male or female patients must have relapsed refractory (r/r) CD19 or CD22 -expressing ALL or Lymphoma/CLL and meet the following disease-specific criteria.
- Cohort I: Lymphoma (Richter's Transformation /Burkitt lymphoma/NHL/CLL), Adults ≥18 years of age:
- Disease entities: Patients with relapsed or refractory (r/r) B-cell lymphoid malignancies according to the WHO Classification of Haematolymphoid Tumours (5th edition), including:
- B-lymphoblastic lymphoma
- Chronic lymphocytic leukemia (CLL)
- Splenic B-cell lymphoma
- Marginal zone lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Diffuse large B-cell lymphoma (DLBCL) / Large B-cell lymphoma
- Burkitt lymphoma
- Transformed indolent B-cell lymphoma (including Richter's transformation)
- Prior treatment and disease status: Patients must meet one of the following criteria:
- Relapsed or refractory disease after ≥2 prior systemic therapies, including at least one of the following (if clinically indicated and available):
- Approved CAR-T cell therapy, or
- Bispecific antibody therapy OR
- Contraindication to CAR-T cell therapy and/or bispecific antibody therapy
- CLL-specific: Patients with relapsed or refractory CLL:
- After failure of established and approved treatment options
- Including prior exposure to BTK inhibitor-based therapy
- Transplant-related eligibility: Patients fulfilling at least one of the following:
- Indication for autologous or allogeneic stem cell transplantation (SCT) as determined by a multidisciplinary board, but ineligible for SCT, or declining SCT after informed consent discussion
- Patients with refractory disease currently precluding alloSCT, including those considered for bridging to allogeneic SCT within the study framework
- Post-transplant or post-targeted therapy relapse: Patients meeting at least one of the following:
- Relapse following autologous or allogeneic SCT
- Relapse following CD19- or CD22-directed therapy
- Confirmed expression of CD19 or CD22 at relapse
- Central nervous system (CNS) involvement
- Patients with CNS involvement by lymphoma are eligible
- Provided that CNS disease is adequately controlled at the time of study inclusion Or
- Cohort II: Acute B-lymphoplastic Leukemia (B-ALL), pediatric patients aged ≥ 12 - 17 years:
- Patients with second or later relapse of ALL with >5% blasts in BM or rising molecular failure on two separate measurements and without an approved option for in label CAR-T cells or bispecific or cytotoxic antibody treatment.
- Patients with relapse after SCT or other CD19 or CD22 targeted treatment with confirmed either CD19 or CD22 expression after relapse.
- Patients not consenting or ineligible for allogeneic SCT or have refractory disease activity precluding allogemeoc SCT at this time, or
- Patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs.
- ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully controlled by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy).
- Patients with ALL in hematologic remission after induction treatment, but ineligible for full execution of further standardly recommended treatments because of medical or other reasons.
Who cannot join
- Subject received any of the following within the last 7 days of leukapheresis:
- Any investigational agent
- Immunsupressive medication
- Plasmapheresis
- Major surgery (as defined by the investigator)
- Radiation therapy other than local therapy for underlying malignancy
Show all 35Show fewer
- Use of any systemic anti-neoplastic drug therapy or immune suppressive medication applied for graft versus-host-disease or other, including the use of high dose steroids e.g. >0,5 mg/kg BW methylprednisolone other than hydrocortisone replacement and other than intermittent topical, inhaled or intranasal corticosteroids which are allowed
- Subject has ECOG ≥ 3 at screening for inclusion in the trial
- Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Subject has any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 500/μL
- Platelet count < 50,000 mm3 (platelet transfusion allowed)
- Serum Creatinine Clearance (CrCl) < 30 mL/min
- Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN)
- Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome or if part of disease involvement
- International ratio (INR) or partial thromboplastin time (PTT) > 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)
- Patient has no adequate vascular access for leukapheresis
- Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction < 40%
- Patient with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 3 months prior to starting study treatment
- Inadequate pulmonary function defined as oxygen saturation (Sa02) < 90 % on room air
- Subject has history of primary immunodeficiency
- Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C or active hepatitis A
- Subject with ongoing (incl. controlled) infections or infestations where inclusion of the patient into the clinical trials may significantly jeopardize the health and wellbeing of the patient, as determined by the investigator.
- Subject with malignancy other than the underlying malignancy in this protocol, unless this disease has been controlled for ≥ 1 year and the exception of the following noninvasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative
- Patient is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study
- Patient with known hypersensitivity to any component of MB-CART2219.1 product, cyclophosphamide, fludarabine, and/or tocilizumab
- Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Patient has any further condition including the presence of further laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital , Department of Internal Medicine II
Tübingen, Baden-Wurttemberg, 72076
Wolfgang Bethge, Prof. Dr., +49 7071 29-83176, Wolfgang.Bethge@med.uni-tuebingen.de
Christoph Faul, Dr., +49 7071 29-84087, Christoph.Faul@med.uni-tuebingen.de
- Not yet recruiting
University Hospital, Clinic for Pediatric Medicine
Tübingen, Baden-Wurttemberg, 72076
Tim Flaadt, Dr., +49 7071 29-80894, Tim.Flaadt@med.uni-tuebingen.de
Peter Lang, Prof. Dr., +49 7071 29-80894, Peter.Lang@med.uni-tuebingen.de
About this study
Official title: A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies
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
- Lymphoma, CLL, Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- CAR-T cells targeting CD19 and CD22
- Keywords
- MB-CART2219.1 targeting CD19/CD22, CD19/CD22, CAR-T cells
- Medical subject headings
- Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cells targeting CD19 and CD22Biological
Using the 3+3 design, the following dose levels will be assessed:
Dose level 1: 0.5x10e6 CAR-transduced T cells/kg; Dose level 2: 1x10e6 CAR-transduced T cells/kg; Dose level 3: 2x10e6 CAR-transduced T cells/kg; Dose level 0: 0.25x10e6 CAR-transduced T cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Dose finding | Experimental | Phase I dose finding and efficacy study using the 3+3 design Receives: Biological: CAR-T cells targeting CD19 and CD22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility Phase I (CTCAE)
Objective: to assess feasibility, safety of ex vivo generated MB-CART2219.1 in patients with relapsed or refractory CD19 and/or CD22 positive B cell malignancies. Determination of the recommended dose of MB-CART-CD19CD22, determined on the basis of the maximum tolerated dose, defined as the highest dose level of the 2-3 dose levels tested at which <33% of patients experience DLT until d+28 after infusion of MBCART2219.1 and on the basis of the safety and efficacy data. Safety and toxicity assessment of MB-CART2219.1 per adverse events reporting classified according to CTCAE version 5.0 defined by <33% of patients experiencing DLT, or maximal administered dose. The Trial uses two separate disease and age specific cohorts for dose escalation: cohort I (Lymphoma incl. CLL, adults) and cohort II (ALL, children). For each cohort in using the standard 3+3 design, three dose levels will be assessed. Feasibility will be defined as successful treatment without major deviation from the protocol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start23 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Bethge, Prof. Dr., Principal investigator, University Hospital Tuebingen, Department of Internal Medicine IITim Flaadt, Dr., Principal investigator, University Hospital Tuebingen, Department of Pediatrics and Adolescent Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108868
- Sponsor's protocol ID
- MB-CART2219.1
- Other IDs
- 2024-516838-35-00
- Status last verified
- Nov 2026
- First submitted
- 24 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT07108868
- Acronym / sponsor ID
- MB-CART2219.1
- Conditions
- Lymphoma, CLL, Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- MB-CART2219.1 targeting CD19/CD22, CD19/CD22, CAR-T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose finding | Experimental | Biological: CAR-T cells targeting CD19 and CD22Phase I dose finding and efficacy study using the 3+3 design |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (44 listed)
- For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- For Cohort II ALL, pediatric patients: Subject is ≥ 12-17 years of age at the time of signing ICF.
- Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.
- CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.
Key exclusion criteria (35 listed)
- Subject received any of the following within the last 7 days of leukapheresis:
- Subject has ECOG ≥ 3 at screening for inclusion in the trial
- Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease
- History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Subject has any of the following laboratory abnormalities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T cells targeting CD19 and CD22Using the 3+3 design, the following dose levels will be assessed: Dose level 1: 0.5x10e6 CAR-transduced T cells/kg; Dose level 2: 1x10e6 CAR-transduced T cells/kg; Dose level 3: 2x10e6 CAR-transduced T cells/kg; Dose level 0: 0.25x10e6 CAR-transduced T cells/kg | Biological | Dose finding |
Primary outcome
Safety and feasibility Phase I (CTCAE)
Time frame: 6 months
Objective: to assess feasibility, safety of ex vivo generated MB-CART2219.1 in patients with relapsed or refractory CD19 and/or CD22 positive B cell malignancies. Determination of the recommended dose of MB-CART-CD19CD22, determined on the basis of the maximum tolerated dose, defined as the highest dose level of the 2-3 dose levels tested at which <33% of patients experience DLT until d+28 after infusion of MBCART2219.1 and on the basis of the safety and efficacy data. Safety and toxicity assessment of MB-CART2219.1 per adverse events reporting classified according to CTCAE version 5.0 defined by <33% of patients experiencing DLT, or maximal administered dose. The Trial uses two separate disease and age specific cohorts for dose escalation: cohort I (Lymphoma incl. CLL, adults) and cohort II (ALL, children). For each cohort in using the standard 3+3 design, three dose levels will be assessed. Feasibility will be defined as successful treatment without major deviation from the protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wolfgang Bethge, Prof. Dr. principal investigator
University Hospital Tuebingen, Department of Internal Medicine II
Tim Flaadt, Dr. principal investigator
University Hospital Tuebingen, Department of Pediatrics and Adolescent Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAR-T cells targeting CD19 and CD22 in people with Lymphoma and CLL, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 44 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Bethge, Prof. Dr. (+49 7071 29-83176, Wolfgang.Bethge@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility Phase I (CTCAE) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.