B Cell LymphomaPhase 1NCT06544265
SynKIR-310 for Relapsed/Refractory B-NHL
A Phase 1 study testing SynKIR-310 in people with B Cell Lymphoma and NHL, Adult, run by Verismo Therapeutics at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma, NHL, Adult, Mantle Cell Lymphoma
- What is being tested?
- SynKIR-310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Nov 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
- If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial
- Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Who cannot join
- Previously treated with any investigational agent within 30 days prior to screening.
- Any previous or concurrent malignancy, with the following exceptions:
- 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.
- 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.
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- Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
- Any active uncontrolled systemic fungal, bacterial or viral infection.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Molly Stoddart, 404-778-6547, molly.stoddart@emoryhealthcare.org
Edmund Waller, MD, PhD
- Recruiting
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver, Colorado, 80218
Cicelia Veloz, 720-754-8068, cicelia.veloz@sarahcannon.com
Autumn Wagner, 720-754-8068, autumn.wagner@scri.com
- Recruiting
The University of Kansas Cancer Center
Fairway, Kansas, 66205
Nurse Navigator, 913-945-7552, CTNurseNav@kumc.edu
Joseph McGuirk, DO
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08902
Hem/Onc Clinical Trial Lab Manager, 732-235-7315, tn293@cinj.rutgers.edu
Matthew Matasar, MD
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brittany Koch, 215-776-5548, brittany.koch@pennmedicine.upenn.edu
Stephen Schuster, MD
About this study
Official title: A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
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.
Read the detailed description
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.
- Conditions
- B Cell Lymphoma, NHL, Adult, Mantle Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Aggressive B-Cell Non-Hodgkin Lymphoma
- Being tested
- SynKIR-310
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Large B-Cell, Diffuse, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynKIR-310Biological
Autologous T Cells transduced with CD19 KIR-CAR
| Study group | Role | What they receive |
|---|---|---|
| SynKIR-310 | Experimental | Single dose IV administration of SynKIR-310 Receives: Biological: SynKIR-310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months
Recommended Phase 2 Dose (RP2D)
All available data from dose escalation cohorts will be evaluated to determine RP2D
Measured: Up to 24 months
Secondary outcomes (5)
Feasibility of SynKIR-310
Number of enrolled patients who pass screening but do not receive SynKIR-310
Measured: Up to 24 months
Preliminary efficacy : Objective response rate (ORR)
Percentage of patients with a complete or partial response determined by Investigator
Measured: Up to 24 months
Preliminary efficacy: Complete response rate (CR)
Percentage of patients with a Complete Response determined by Investigator
Measured: 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
Measured: 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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Nov 2024
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verismo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura A Johnson, PhD, Study chair, Verismo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544265
- Sponsor's protocol ID
- CELESTIAL-301
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06544265
- Acronym / sponsor ID
- CELESTIAL-301
- Conditions
- B Cell Lymphoma, NHL, Adult, Mantle Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Aggressive B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Verismo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SynKIR-310 | Experimental | Biological: SynKIR-310Single dose IV administration of SynKIR-310 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
Key exclusion criteria (9 listed)
- Previously treated with any investigational agent within 30 days prior to screening.
- Any previous or concurrent malignancy, with the following exceptions:
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynKIR-310Autologous T Cells transduced with CD19 KIR-CAR | Biological | SynKIR-310 |
Primary outcome
Evaluate the safety of SynKIR310
Time frame: Up to 24 months
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
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 24 months
All available data from dose escalation cohorts will be evaluated to determine RP2D
5 secondary outcomes
Feasibility of SynKIR-310
Time frame: Up to 24 months
Preliminary efficacy : Objective response rate (ORR)
Time frame: Up to 24 months
Preliminary efficacy: Complete response rate (CR)
Time frame: Up to 24 months
Preliminary efficacy: Duration of response (DOR)
Time frame: Up to 24 months
PK profile of SynKIR-310
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura A Johnson, PhD study chair
Verismo Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SynKIR-310 in people with B Cell Lymphoma and NHL, Adult, run by Verismo Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Physician Connect (267-392-6847 ext. 267-392-6847, physician.connect@verismotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of SynKIR310 (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.