A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07564401
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

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

Interventions

  • DJI136 — DRUG
    DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.

Study Details

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.

Key Dates

Start date
May 14, 2026
Status verified
May 2026
Primary completion
Mar 3, 2031
Completion
Mar 3, 2031

Study Design

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

Arms

  • Experimental: Phase I
    Dose escalation with DJI136
  • Experimental: Phase II
    Treatment at the recommended dose(s) of DJI136 as identified in Phase I.

Primary Outcome Measure

All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Zheng Zhang
[email protected]
713-792-0007
Bingnan Zhang (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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