Non Hodgkin Lymphoma Clinical Trial

Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

Summary

This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

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Full Description

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. The study will follow a 3+3 design during dose escalation. Cohort A will enroll subjects to SYNCAR-001 + STK-009 with lymphodepletion. At Dose Level 3, a separate dose escalation cohort will be introduced to enroll subjects to SYNCAR-001 + STK-009 without lymphodepletion (Cohort B). Subsequent dose expansions will enroll subjects at the RP2D for each cohort.

View Eligibility Criteria

Eligibility Criteria

Selected Inclusion Criteria:

Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)
Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology
No signs of symptoms of central nervous system (CNS) disease or detectable evidence of CNS or meningeal disease on magnetic resonance imaging (MRI) at the time of screening

Selected Exclusion Criteria:

Prior CD19 directed therapy including CD19 CARTs
Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment
Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment.
Presence of GVHD

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT05665062

Recruitment Status:

Recruiting

Sponsor:

Synthekine

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There are 4 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Michael Mei, MD
Contact
626-218-1133
Roswell Park
Buffalo New York, 14263, United States More Info
Megan Hughes
Contact
716-845-1300
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
General CART Inquiry Email
Contact
[email protected]
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Cancer Awareness Line
Contact
216-444-2200

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

36

Study ID:

NCT05665062

Recruitment Status:

Recruiting

Sponsor:


Synthekine

How clear is this clinincal trial information?

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