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TERN-701 for Chronic Myeloid Leukemia (CARDINAL Study)

This study is testing a new medication called TERN-701 for people with chronic myeloid leukemia (CML) in the chronic phase. TERN-701 is designed to block a specific protein (BCR-ABL1) that helps CML cells grow. The main goals are to see how safe TERN-701 is, how well your body handles it, and if it helps treat CML. You might be able to join if you are 18 or older, have CML in the chronic phase, and have already tried at least one other CML medication that didn't work well or caused side effects. The study will look at side effects and how well the treatment works over time. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 180 participants. It has two parts: Part 1 will test different doses of TERN-701, and Part 2 will further evaluate the safety and effectiveness of selected doses.
What's involved
TERN-701 will be taken by mouth once daily. The study will monitor for side effects for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for serious adverse events and adverse events for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06163430

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
~180 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:TERN-701

At a glance

Recruiting sites
48 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment
Measured over First cycle is 28 days
+5 more outcomes measured

Conditions

Chronic Myeloid Leukemia, Chronic Phase
Chronic Myeloid Leukemia

Explore related trials

Chronic Myeloid Leukemia, BCR-ABL1 PositiveBCR/ABL1 Fusion Gene

Where it's being run

54 sites across 27 states
Spain8
Germany7
France5
Florida4
Italy4
Oregon2
Victoria2
New Zealand2

Who to contact

Study Director
[email protected]
650-525-5535
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female participants ≥ 18 years of age at the time of signing the informed consent
Have an ECOG performance status score of 0 to 2
Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance
Prior treatment with asciminib is allowed
Adequate organ function, as assessed by local laboratory

Exclusion

Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)

What this trial measures

  • Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatmentFirst cycle is 28 days

    Determination of the Maximum Tolerated Dose (MTD) and recommended doses for expansion cohorts of TERN-701.

  • Part 1 - Serious Adverse Eventsup to 3 years

    Number and percentage of patients with any serious adverse event

  • Part 1 - Adverse Eventsup to 3 years

    Number and percentage of patients with any adverse event

  • Part 2- Complete Hematologic Response (CHR)up to 3 years

    CHR Defined by ELN 2020 criteria in participants who are not in CHR at baseline.

  • Part 2: Molecular response (MR)up to 3 years

    MR defined by ELN 2020 criteria measured by quantitative polymerase chain reaction of BCR-ABL transcript levels.

  • Part 2 - Best categorical shift in BCR-ABL1 transcript levels from baselineup to 3 years

    The best categorical molecular response shift on treatment relative to baseline