Health TrialsbyHealthPanel

SynKIR-310 for Relapsed/Refractory B-NHL

ConditionsB Cell LymphomaNHL, AdultMantle Cell LymphomaRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaAggressive B-Cell Non-Hodgkin LymphomaIndolent B-Cell Non-Hodgkin LymphomaFollicular LymphomaMarginal Zone LymphomaDLBCL - Diffuse Large B Cell LymphomaHGBL With MYC and BCL2 and/or BCL6 RearrangementsHigh-grade B-cell LymphomaDiffuse Large B Cell LymphomaLarge B-cell LymphomaT-Cell/Histiocyte Rich LymphomaNon-hodgkin Lymphoma,B CellPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Epstein-Barr Virus Positive DLBCL, NosFollicular Lymphoma Grade 3BDLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic InflammationHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedFollicular Lymphoma Grade 3Marginal Zone Splenic LymphomaDLBCLWaldenstrom MacroglobulinemiaWaldenstrom Macroglobulinaemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVerismo Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult 18 years of age and older.

Histologically confirmed diagnosis of B-NHL before enrollment.

Must have received prior CAR T or were unwilling/unable to receive prior CAR T.

Must have refractory or relapsed disease after receiving 2 prior lines of therapies.

Disqualifiers

Previously treated with any investigational agent within 30 days prior to screening.

Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis

Known immunodeficiency disease , with the exception of hypoglobulinemia

History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.

Trial design

Design model

Single group

Treatments tested in this trial

  • SynKIR-310

    Biological/Vaccine

    Autologous T Cells transduced with CD19 KIR-CAR

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: SynKIR-310Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 24 months
2

Recommended Phase 2 Dose (RP2D)

All available data from dose escalation cohorts will be evaluated to determine RP2D

Time frame
Up to 24 months

Secondary outcomes

1

Feasibility of SynKIR-310

Number of enrolled patients who pass screening but do not receive SynKIR-310

Time frame
Up to 24 months
2

Preliminary efficacy : Objective response rate (ORR)

Percentage of patients with a complete or partial response determined by Investigator

Time frame
Up to 24 months
3

Preliminary efficacy: Complete response rate (CR)

Percentage of patients with a Complete Response determined by Investigator

Time frame
Up to 24 months
4

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

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Verismo Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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