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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06434363
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tafasitamab — DRUG
    Given by vein (IV)
  • Fludarabine phosphate — DRUG
    Given by vein (IV)
  • Cyclophosphamide — DRUG
    Given by vein (IV)
  • Tafasitamab and NK cells — DRUG
    Given by vein (IV)

Study Details

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. The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.

Key Dates

Start date
Jul 31, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
47 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In
  • Experimental: Dose Escalation
  • Experimental: Dose Expansion

Primary Outcome Measure

Adverse Event [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Chitra Chitra, MD
[email protected]
713-745-3219
Chitra Hosing, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Shervin Assassi, MD
[email protected]
713-500-7118
Shervin Assassi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
MD Anderson Cancer Center· Houston, TXThe University of Texas Health Science Center at Houston· Houston, TX

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