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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT05143996
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelodysplastic Syndrome (MDS)
  • Relapsed/Refractory Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLN-049 — DRUG
    \[FLT3\] x \[CD3\] bispecific T cell engager

Study Details

CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Key Dates

Start date
Nov 18, 2021
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Single ascending dose (SAD) design of IV administered CLN-049
    Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration
  • Experimental: Part B - Multiple ascending dose (MAD) design of IV administered CLN-049
    Patients with relapsed/refractory AML or MDS will receive CLN-049 via IV administration
  • Experimental: Part C - Multiple ascending dose (MAD) design of SC administered CLN-049
    Patients with relapsed/refractory AML or MDS will receive CLN-049 via SC injection

Primary Outcome Measure

Number of treatment emergent events (TEAEs) [ Time Frame: 28 days ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama O'Neal Cancer CenterBirminghamAlabama35233
Anne C Durena
[email protected]
205-801-9034
Kimo Bachiashvili, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Bruck Habtemariam
[email protected]
Gary Schiller (PRINCIPAL_INVESTIGATOR)
University of Miami Health SystemMiamiFlorida33136
Jennifer Posada
[email protected]
305-243-2647
Namrata Chandhok, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Fernando Bustamante
[email protected]
Onyee Chan (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Lindsey E. Overman
[email protected]
William Blum (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114-
Roswell Park Cancer InstituteBuffaloNew York14263
Wendy Walinski
[email protected]
1-800-767-9355
Eunice Wang, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Rachel Joseph
[email protected]
Mohammad Maher Abdul Hay (PRINCIPAL_INVESTIGATOR)
Duke Cancer CenterDurhamNorth Carolina27710
Samuel Dell
[email protected]
919-681-5698
Sanghee Hong, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
MD AndersonHoustonTexas77030
Allison Pike
[email protected]
Ghayas Issa (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama O'Neal Cancer Center· Birmingham, ALUCLA· Los Angeles, CAUniversity of Miami Health System· Miami, FLMoffitt Cancer Center· Tampa, FLEmory University Hospital· Atlanta, GAMassachusetts General Hospital· Boston, MA

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