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NCT07564401 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target

NCT07564401: Recruiting Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT07564401 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07564401, a Phase 1 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study Summary

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.

Primary Outcome

Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

Interventions

  • DRUG DJI136

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2026-06-16
Est. Completion 2031-03-03
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What NCT07564401 shows while recruiting

NCT07564401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).

The record links to 0 conditions, and to 1 intervention - of which DJI136 is the first listed.

NCT07564401 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07564401 about?

NCT07564401 is a clinical study titled "A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy". 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.

What is the current status of trial NCT07564401?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2026-06-16. Estimated completion is 2031-03-03.

What interventions are being tested in trial NCT07564401?

The interventions under investigation include: DJI136 (DRUG).

Who is sponsoring clinical trial NCT07564401?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07564401's enrollment target sits among peer trials

80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07564401, the US trial registry maintained by the National Library of Medicine. NCT07564401 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.