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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing CAR-T cells targeting CD19 and CD22 for Lymphoma

A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies

Official registry: https://clinicaltrials.gov/study/NCT07108868 · University Hospital Tuebingen · enrollment listed as 36

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CAR-T cells targeting CD19 and CD22. The registry lists allocation as na. A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies

They plan to enroll about 36 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: CAR-T cells targeting CD19 and CD22

Primary outcome (registry wording): Safety and feasibility Phase I (CTCAE)

Who it is for (from inclusion criteria)

  • Ages 12 Years to 75 Years
  • For Cohort II ALL, pediatric patients: Subject is ≥ 12-17 years of age at the time of signing ICF
  • 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
  • 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:

Public study contact (from the registry)

Wolfgang Bethge, Prof. Dr.

+49 7071 29-83176

Wolfgang.Bethge@med.uni-tuebingen.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07108868 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07108868?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07108868?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary