RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing CAR20(NAP)-T for B-cell Lymphoma

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

Official registry: https://clinicaltrials.gov/study/NCT06002659 · Uppsala University · enrollment listed as 18

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more 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 CAR20(NAP)-T, Cyclophosphamide, or Fludarabine. The registry lists allocation as na. The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and how well it works of CAR20(NAP)-T for patients with B-cell malignancies.

They plan to enroll about 18 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase I/IIa Multicenter Study Evaluating the Safety and Efficacy of CAR20(NAP)-T in Patients With Relapsed/Refractory B Cell Lymphoma (CARMA-01 Study)

Interventions: CAR20(NAP)-T, Cyclophosphamide, Fludarabine

Primary outcome (registry wording): Incidence of dose limiting toxicity

Who it is for (from inclusion criteria)

Relapsed or refractory CD20+ large B-cell lymphoma (DLBCL, NOS or high-grade malignant B-cell lymphoma), mantle cell lymphoma or indolent lymphoma
The patient should have been treated with at least one line of therapy and have no curative treatment option, assessed by the Investigator and documented in the source data prior to enrolment, specifically:
Relapsed or refractory CD20+ B-cell lymphoma that are not suitable to receive clinically approved CD19-directed CAR T cell treatment
Relapsed or refractory CD20+ B-cell lymphoma who are considered CD19 neg-ative
Relapsed or refractory B-cell lymphoma who relapse after CD19-directed CAR T cell treatment
Not suitable for autologous stem cell transplant
Relapsed after allogeneic transplantation

Who the registry excludes

Other CD20-positive lymphomas e.g Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation)
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 tolerate the treatment
Treatment with an investigational product within 30 days prior to enrolment

Public study contact (from the registry)

Gunilla Enblad, MD/PhD

+46186110000

gunilla.enblad@igp.uu.se

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

Sites listed on ClinicalTrials.gov

2 listed

Karolinska University Hospital — Stockholm, Sweden (recruiting)
Uppsala University Hospital — Uppsala, Sweden (recruiting)

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FAQ about this NCT record

Is NCT06002659 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 NCT06002659?

Phase 1 / Phase 2. 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 NCT06002659?

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