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

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

First listed

May 4, 2026

Start date

Jun 16, 2026

Status verified

Jun 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 (3)

Find similar trials in Lexington, KY

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