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CLN-049 for Leukemia and Myelodysplastic Syndrome

Q: What is the upper limit for participants in this clinical experiment?

This medical trial demands the enrollment of 60 individuals who meet its entry requirements. Potential participants can be found at either Emory University Hospital in Atlanta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> or UCLA in Los Angeles, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: How many sites in Canada are conducting this clinical research?

The trial is currently inviting participants to join from 7 different medical sites, located in several cities including Atlanta, Los Angeles and Tampa. It may be advantageous for you if the closest centre to your area of residence participates so as to reduce travel demands.

Q: What perils could individuals face when exposed to CLN-049?

CLN-049's safety profile has been evaluated as a 1 on the Power scale due to it being in its initial clinical testing stage, where data supporting efficacy and safety is still limited.

Q: Are there still vacancies available to participate in this experiment?

Affirmative. The information found on clinicaltrials.gov confirms that the trial is recruiting participants, with an original posting date of November 18th 2021 and a recent update on December 6th 2022. This study needs to acquire 60 individuals from 7 distinct locations.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My diagnosis is recurrent or refractory AML or MDS.

Select...

My white blood cell count is below 20,000/uL.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 18 years old or older.

Select...

My condition worsened or didn't improve with standard treatments, or I chose not to undergo them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cmax of CLN-049

Ctrough of CLN-049

Therapeutic procedure

+2 more

Secondary outcome measures

Immunogenicity of CLN-049

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cullinan Therapeutics Inc.Lead Sponsor

5 Previous Clinical Trials

708 Total Patients Enrolled

Cullinan Oncology Inc.Lead Sponsor

5 Previous Clinical Trials

708 Total Patients Enrolled

Cullinan Oncology, LLCLead Sponsor

6 Previous Clinical Trials

992 Total Patients Enrolled

Media Library

CLN-049 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05143996 — Phase 1

Acute Myeloid Leukemia 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

Acute Myeloid Leukemia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participants in this clinical experiment?

"This medical trial demands the enrollment of 60 individuals who meet its entry requirements. Potential participants can be found at either Emory University Hospital in Atlanta, Georgia or UCLA in Los Angeles, California."

Answered by AI

How many sites in Canada are conducting this clinical research?

"The trial is currently inviting participants to join from 7 different medical sites, located in several cities including Atlanta, Los Angeles and Tampa. It may be advantageous for you if the closest centre to your area of residence participates so as to reduce travel demands."

Answered by AI

What perils could individuals face when exposed to CLN-049?

"CLN-049's safety profile has been evaluated as a 1 on the Power scale due to it being in its initial clinical testing stage, where data supporting efficacy and safety is still limited."

Answered by AI

Are there still vacancies available to participate in this experiment?

"Affirmative. The information found on clinicaltrials.gov confirms that the trial is recruiting participants, with an original posting date of November 18th 2021 and a recent update on December 6th 2022. This study needs to acquire 60 individuals from 7 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

2021. "CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05143996.