IOMAB-CAR-T Followed by CAR-T Cell Therapy in R/R DLBCL

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06768905
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma
  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Iomab-B — DRUG
    single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion.
  • CAR-T cell — DRUG
    CAR-T cell therapy

Study Details

This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.

Key Dates

Start date
Apr 25, 2025
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Safety run-in)
    131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CD-19 CAR-T cell therapy
  • Experimental: Part B (cohort expansion)
    131I-Apamistamab dose will be given 5-7 days prior to a single infusion of CAR-T cell therapy

Primary Outcome Measure

Dose-limiting toxicity (safety) -Part A (safety run-in) [ Time Frame: Start of treatment up to 30 days post CAR T-cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Silviya Meletath
[email protected]
214-648-7097

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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