CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Lymphoma

In brief

The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.

Key facts

Study ID

NCT06002659

Run by

Uppsala University

People needed

18

Starts

2024-05-01

Expected to finish

2027-12-30

Last updated by the study team

2024-05-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Other CD20-positive lymphomas i.e Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation)
• Any significant medical or psychiatric illness that would prevent the subject from giving informed consent or from following the study procedures.
• Known human immunodeficiency virus (HIV) infection.
• Impending organ-compromising disease.
• Rapidly progressing disease
• Active and/or severe infection (e.g., tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
• Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the subject to perform the treatment.
• Treatment with an investigational product within 30 days prior to enrolment
• Potential sign of hypersensitivity reaction to tocilizumab or any of the agents used in this study
• Systemic corticosteroid treatment (>10mg/day) <5 days prior to IMP treatment or <7 days prior leukapheresis.
• Pregnancy

Where it is running

• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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