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CLN-049 for Leukemia and Myelodysplastic Syndrome

Phase 1
Recruiting
Research Sponsored by Cullinan Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has a confirmed diagnosis of recurrent or refractory AML or MDS
White blood cell (WBC) count at the time of the first dose is < 20,000/uL (hydroxyurea is permitted according to standard institutional practice)
Must not have
History of Grade 3 or greater toxicities in conjunction with prior treatment with immunotherapy
Active central nervous system (CNS) leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug to treat relapsed/refractory AML/MDS, a type of blood cancer.

Who is the study for?
Adults diagnosed with recurrent or resistant AML or MDS, who have an ECOG performance status of 0-2 and adequate organ function. They must not have had certain treatments recently, like CAR-T therapy or allogeneic hematopoietic transplantation within six months. Participants need to be able to consent and follow the trial procedures.
What is being tested?
The study is testing CLN-049 in a Phase 1 trial for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has come back or hasn't responded to treatment. It's an open-label, multicenter trial where everyone knows what treatment they're getting.
What are the potential side effects?
Specific side effects of CLN-049 are not listed but may include typical reactions seen with cancer therapies such as immune-related issues, infusion reactions, blood count changes, fatigue, liver enzyme elevations, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is recurrent or refractory AML or MDS.
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My white blood cell count is below 20,000/uL.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My condition worsened or didn't improve with standard treatments, or I chose not to undergo them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced severe side effects from previous immunotherapy.
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My leukemia has spread to my brain or spinal cord.
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I am not incapacitated or involuntarily incarcerated.
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I have received an organ transplant from another person.
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I have or might have had an autoimmune disease.
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I had a bone marrow transplant less than 6 months ago, or I have signs of GVHD, or need ongoing immune suppression.
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I have a history of HIV, hepatitis B, hepatitis C, or COVID-19.
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I have received treatments like radiation or immunotherapy.
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I have not been treated for another cancer in the past year.
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My cancer has returned outside the bone marrow.
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I have been diagnosed with acute promyelocytic leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cmax of CLN-049
Ctrough of CLN-049
Therapeutic procedure
+2 more
Secondary study objectives
Immunogenicity of CLN-049

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C - Multiple ascending dose (MAD) design of SC administered CLN-049Experimental Treatment1 Intervention
Patients with relapsed/refractory AML or MDS will receive CLN-049 via SC injection
Group II: Part B - Multiple ascending dose (MAD) design of IV administered CLN-049Experimental Treatment1 Intervention
Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration
Group III: Part A - Single ascending dose (SAD) design of IV administered CLN-049Experimental Treatment1 Intervention
Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration

Find a Location

Who is running the clinical trial?

Cullinan Therapeutics Inc.Lead Sponsor
7 Previous Clinical Trials
702 Total Patients Enrolled
Cullinan Oncology Inc.Lead Sponsor
5 Previous Clinical Trials
648 Total Patients Enrolled
Cullinan Oncology, LLCLead Sponsor
6 Previous Clinical Trials
932 Total Patients Enrolled

Media Library

CLN-049 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05143996 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Part A - Single ascending dose (SAD) design of IV administered CLN-049, Part B - Multiple ascending dose (MAD) design of IV administered CLN-049, Part C - Multiple ascending dose (MAD) design of SC administered CLN-049
Myelodysplastic Syndrome Clinical Trial 2023: CLN-049 Highlights & Side Effects. Trial Name: NCT05143996 — Phase 1
CLN-049 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143996 — Phase 1
~11 spots leftby Aug 2025
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