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New treatment option for B Cell Lymphoma
Official title SynKIR-310 for Relapsed/Refractory B-NHL
ClinicalTrials.gov ID: NCT06544265
What this study is testing
What is SynKIR-310?
SynKIR-310 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of...
- 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...
- Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or...
See the full eligibility criteria
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- Fairway, Kansas, United States
- New Brunswick, New Jersey, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Atlanta, Georgia, United States; Fairway, Kansas, United States; New Brunswick, New Jersey, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.