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

NCT07108868 | Recruiting Phase 1 DMC

• 2 other identifiers: MB-CART2219.12024-516838-35-00
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Lymphoma; CLL; Acute Lymphoblastic Leukemia, Pediatric

Keywords

MB-CART2219.1 targeting CD19/CD22; CD19/CD22; CAR-T cells

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (1)

Dose finding

EXPERIMENTAL

Phase I dose finding and efficacy study using the 3+3 design

Biological: CAR-T cells targeting CD19 and CD22

Interventions

CAR-T cells targeting CD19 and CD22 BIOLOGICAL

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

Dose finding

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, pediatrics: Subject is ≥ 12 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.
• 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.
• 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.
• 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
• B-Chronic lymphocytic leukemia
• Splenic B-cell lymphoma
• Marginal zone lymphoma
• Follicular lymphoma
• Mantle cell lymphoma
• Large B-cell lymphoma

You may not qualify if:

• 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
• 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
• Absolute lymphocyte count \< 200/µL at time of leukapheresis
• Platelet count \< 50,000 mm3 (platelet transfusion allowed)
• Serum Creatinine Clearance (CrCl) \< 45 mL/min
• Corrected serum calcium \> 13.5 mg/dL (\> 3.4 mmol/L)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (2)

University Hospital , Department of Internal Medicine II

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

University Hospital, Clinic for Pediatric Medicine

Tübingen, Baden-Wurttemberg, 72076, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)