Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Tafasitamab for Autoimmune Disorders

The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.

Official registry: https://clinicaltrials.gov/study/NCT06434363 · M.D. Anderson Cancer Center · enrollment listed as 47

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 Tafasitamab, Fludarabine phosphate, or Cyclophosphamide. The registry lists allocation as randomized. The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.

They plan to enroll about 47 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

Interventions: Tafasitamab, Fludarabine phosphate, Cyclophosphamide, Tafasitamab and NK cells

Primary outcome (registry wording): Adverse Event

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • SSc Specific who can join
  • A. Diagnosis of SSc defined as follows:
  • i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening
  • B. SSc disease activity i) Diffuse SSc meeting the following criteria:
  • Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):
  • (i) Increased extent or severity of traction bronchiectasis and bronchiolectasis
  • (ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality

Public study contact (from the registry)

Chitra Chitra Hosing, MD

(713) 745-3219

cmhosing@mdanderson.org

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 NCT06434363 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 NCT06434363?

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 NCT06434363?

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