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This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed/refractory B-NHL.
This is a Phase 1, FIH, multicenter, open-label study of a single infusion of SynKIR-310 in participants with relapsed/refractory B-NHL.
Up to 36 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study.
Up to 4 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-310. Doses will be escalated across up to 4 cohorts to determine a Recommended Phase 2 Dose (RP2D).
Once the RP2D has been determined, a dose expansion group will enroll additional participants regardless of subtypes of B-NHL at the RP2D to further characterize the safety, feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynKIR-310 | Experimental | Single dose IV administration of SynKIR-310 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynKIR-310 | Biological | Autologous T Cells transduced with CD19 KIR-CAR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of SynKIR310 | The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs). Presence of RCL-VSV-G | Up to 24 months |
| Recommended Phase 2 Dose (RP2D) | All available data from dose escalation cohorts will be evaluated to determine RP2D | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of SynKIR-310 | Number of enrolled patients who pass screening but do not receive SynKIR-310 | Up to 24 months |
| Preliminary efficacy : Objective response rate (ORR) | Percentage of patients with a complete or partial response determined by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level < 1.0 may also be permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Physician Connect | Contact | 267-392-6847 | 267-392-6847 | physician.connect@verismotherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Laura A Johnson, PhD | Verismo Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
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| Up to 24 months |
| Preliminary efficacy: Complete response rate (CR) | Percentage of patients with a Complete Response determined by Investigator | Up to 24 months |
| Preliminary efficacy: Duration of response (DOR) | Time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause, determined by Investigator | Up to 24 months |
| PK profile of SynKIR-310 | To evaluate the patients who show CAR T persistence in blood (measured in the blood by quantitative polymerase chain reaction (PCR)) at multiple study time points following SynKIR-310 infusion | Up to 24 months |
| Winship Cancer Institute of Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| The University of Kansas Cancer Center | Recruiting | Fairway | Kansas | 66205 | United States |
|
| Rutgers Cancer Institute | Recruiting | New Brunswick | New Jersey | 08902 | United States |
|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D046248 | Pyloric Stenosis, Hypertrophic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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