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New treatment option for Lymphoma
Official title A Phase I Dose Finding Study of MB-CART2219.1
ClinicalTrials.gov ID: NCT07108868
What this study is testing
What is CAR-T cells targeting CD19 and CD22?
CAR-T cells targeting CD19 and CD22 is an investigational medicine, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join 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...
- CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the...
You likely can't join 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
See the full eligibility criteria
Who can 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, 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.
- 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...
- Female Subject of childbearing potential and male people with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.
- All people 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...
- B-lymphoblastic lymphomas
- B-Chronic lymphocytic leukemia
- Splenic B-cell lymphoma
- Marginal zone lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Large B-cell lymphoma
- Burkitt lymphoma
- Transformation from indolent lymphoma
- Patients with r/r CLL after established and approved treatment options including therapy with BTK inhibitors have failed
- Patients with lymphoma recommended for autologous or allogeneic stem cell transplant (SCT) therapy by interdisciplinary boards, but not consenting or ineligible for this treatment (including patients with refractory...
- Patients with lymphoma relapse after SCT, or afterCD19 or CD22 targeting therapies and with confirmed either CD19 or CD22 expression after relapse
- Patients with CNS involvement by lymphoma are eligible if disease is successfully controlled at the time of inclusion
What rules you out
- 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...
- 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...
- 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)
- 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 people with documented Gilbert's syndrome
- 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...
- Patient has no adequate vascular access for leukapheresis
- Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction \< 45%
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.