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

First listed
Jan 10, 2025
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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