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A Phase I Dose Finding Study of MB-CART2219.1 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase I Dose Finding Study of MB-CART2219.1

A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies

NCT07108868•University Hospital Tuebingen

View on ClinicalTrials.gov

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

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
•2. For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF.
•3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
•4. 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.
•5. 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.
•6. 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.
•7. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.
•8. 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.
•1. Patients with r/r lymphoma with following entities according to 5th edition of the WHO Classification of Haematolymphoid Tumors after two or more systemic therapies, including one approved in label CAR-T-cell or bispecific antibody treatment option or with contraindications for such treatments:
•* B-lymphoblastic lymphomas
+11 more criteria

Exclusion Criteria

•1. 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
•* 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
•2. Subject has ECOG \> 3 at screening for inclusion in the trial
•3. Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease
•4. 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
+26 more criteria

Locations (2)

University Hospital , Department of Internal Medicine II

Tübingen, Baden-Wurttemberg, Germany

University Hospital, Clinic for Pediatric Medicine

Tübingen, Baden-Wurttemberg, Germany

Key Dates

Start Date

June 23, 2025

Primary Completion Date

March 1, 2027

Completion Date

June 1, 2027

Last Updated

August 7, 2025

Enrollment

ESTIMATED participants

Conditions

LymphomaCLLAcute Lymphoblastic Leukemia, Pediatric

Interventions

CAR-T cells targeting CD19 and CD22

BIOLOGICAL

Contacts

Wolfgang Bethge, Prof. Dr.

CONTACT

+49 7071 29-83176 Wolfgang.Bethge@med.uni-tuebingen.de

Peter Lang, Prof. Dr.

CONTACT

+49 7071 29-80894 Peter.Lang@med.uni-tuebingen.de

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DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Dose Finding Study of MB-CART2219.1

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

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