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NCT05117476 · ClinicalTrials.gov registry record · Phase 1

A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumor and NSCLC, sponsored by Cullinan Therapeutics.

Active
Registry status
Phase 1
Development phase
440
Enrollment target
20
Study locations

NCT05117476: Active Phase 1 study of Advanced Solid Tumor and NSCLC, sponsored by Cullinan Therapeutics.

NCT05117476 is a Phase 1 study of Advanced Solid Tumor and NSCLC that is active but no longer recruiting, run by Cullinan Therapeutics. The registered enrollment target is 440 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05117476, a Phase 1 study of Advanced Solid Tumor and NSCLC, is active but no longer recruiting, sponsored by Cullinan Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
440 participants
Enrollment target
20
Study locations

Study Summary

CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Primary Outcome

Number of treatment-emergent events (TEAEs) TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.

Interventions

  • DRUG Pembrolizumab
  • DRUG Paclitaxel
  • DRUG pemetrexed
  • DRUG CLN-619
  • DRUG Carboplatin AUC 6

Study Locations (20)

Other

  • Biokinetica - Józefów
  • Med-Polonia Sp. zo. o. - Poznan
  • Narodowy Insytut Onkologii im Marii Sklodowskiej-Curie - Warsaw
  • START Barcelona - Barcelona

California

  • City of Hope - Duarte
  • City of Hope - Irvine

Victoria

  • Monash Health - Clayton
  • Alfred Health - Melbourne

Alabama

  • University of Alabama at Birmingham - Birmingham

Florida

  • Florida Cancer Specialists - Sarasota

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • START Midwest - Grand Rapids

New Jersey

  • Hackensack Meridian Health - Hackensack

Trial Details

FieldValue
Enrollment Target 440 participants
Start Date 2021-10-29
Est. Completion 2026-06
Phase Phase 1
Cullinan Therapeutics

9 total trials

What the registry record for NCT05117476 still lists

NCT05117476 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (130% higher).

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05117476 names 20 study sites across 15 states, led by Other, California, Victoria.

Frequently Asked Questions

What is clinical trial NCT05117476 about?

NCT05117476 is a clinical study titled "A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors". CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

What is the current status of trial NCT05117476?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 440 participants. The study started on 2021-10-29. Estimated completion is 2026-06.

What conditions does trial NCT05117476 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, NSCLC.

What interventions are being tested in trial NCT05117476?

The interventions under investigation include: Pembrolizumab (DRUG), Paclitaxel (DRUG), pemetrexed (DRUG), CLN-619 (DRUG), Carboplatin AUC 6 (DRUG).

Who is sponsoring clinical trial NCT05117476?

This trial is sponsored by Cullinan Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05117476 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05117476's enrollment target sits among peer trials

440 14th of 189 higher than 176 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor 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 NCT05117476, the US trial registry maintained by the National Library of Medicine. NCT05117476 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.