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CLN-049 + Azacitidine + Venetoclax for Leukemia

Not yet recruiting at 4 trial locations
TS
Overseen ByTimna Serino
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Cullinan Therapeutics Inc.
Must be taking: Azacitidine, Venetoclax
Must not be taking: Glucocorticoids, Immunosuppressants
Disqualifiers: Chemotherapy, CNS involvement, Leukostasis, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

A Phase 1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously (IV) administered CLN-049 in combination with azacitidine (Aza) and venetoclax (Ven) in patients with newly diagnosed (ND) AML.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed, untreated acute myeloid leukemia who are not fit for intensive chemotherapy. Participants need good kidney and liver function, controlled white blood cell counts, and must not have certain types of leukemia or active infections.

Inclusion Criteria

I am 18 or older and have newly diagnosed, untreated AML.
White blood cell (WBC) count at C1D1 ≤ 20,000/μL
Laboratory values: Creatinine clearance (CrCl) ≥ 45 mL/min
See 5 more

Exclusion Criteria

I have acute promyelocytic leukemia or PML:RARA-positive AML.
I currently have a severe COVID-19 infection.
QTcF interval ≥ 480 milliseconds
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 in dose escalation cohorts

Variable duration until dose determination

Dose Expansion

Newly diagnosed AML patients treated with standard of care azacitidine and venetoclax in addition to CLN-049 at a dose determined in Part A

Variable duration based on dose expansion

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • CLN-049
  • Venetoclax

Trial Overview

The study tests a new drug called CLN-049 given by IV along with standard drugs azacitidine and venetoclax in people with AML. The main goal is to find the safest dose and check how well patients tolerate this combination.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part B: Dose ExpansionExperimental Treatment3 Interventions
Group II: Part A: Dose EscalationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials
9
Recruited
1,000+

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