CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type (NCT05218408) | Clinical Trial Compass
WithdrawnPhase 1/2
CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type
Stopped: No participants were enrolled. Study was withdrawn prior to treatment initiation.
0Started 2021-09
Plain-language summary
A Phase 1/2a Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001 in Combination with Recombinant Human Interleukin-2 in Adults with Recurrent Resection Eligible IDH1 wild-type Glioblastoma. For phase I portion, the study objectives to assess the safety and feasibility CYNK-001 in combination with rhIL2 of Intravenous (IV) infusion and Intracavitary (IC) administrations following tumor resection and to establish a maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D) for IV and IC CYNK-001 administration. For Phase IIa, to evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM as measured by Progression Free Survival at 6 months (PFS6M)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be 18 years or older of age on the day of signing informed consent.
. Have had historical or current histologically confirmed isocitrate dehydrogenase 1(IDH1) wild-type glioblastoma and variants as defined by the World Health Organization
. Patient must have a T1 weighted 3D MRI with Gadolinium enhancement within 14 days prior to lymphodepletion at Day -5
. Patient must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
. Radiologically confirmed recurrent glioblastoma at first or second recurrence have contrast enhancing measurable disease with a bidimensional diameter greater than or equal to 10 mm x 10 mm according to RANO and be eligible to undergo tumor resection.
. Patients must be a candidate to undergo non-emergent surgical resection of the primary target lesion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial's status shows it was withdrawn before enrolling anyone — do you know why it was pulled, and whether a similar NK cell therapy study for recurrent GBM is currently open that we should look into instead?
2Since this was designed as a Phase 1/2 trial focused on finding a safe dose of CYNK-001, what does that early phase mean in terms of how much would have been known about whether this treatment actually works against IDH-1 wild type glioblastoma?
3The trial was designed to deliver CYNK-001 both intravenously and directly into the brain — how does that kind of intracranial administration compare in terms of risk to more standard treatment approaches you might recommend for my situation?
4Given that this specific trial is no longer recruiting, what are the current standard-of-care options for recurrent GBM with IDH-1 wild type, and would you recommend pursuing one of those before or instead of looking for another experimental NK cell therapy trial?
5Are there any other active clinical trials studying cell-based or immunotherapy approaches for recurrent glioblastoma that you think might be appropriate for me to consider, given my specific tumor profile?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I-Number of patients experience Dose limiting toxicity (DLT)
Timeframe: 42 days
2
To establish maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D)
. Multifocal GBM is permissible in the study if there is contiguous T2FLAIR hyperintensity between enhancing lesions on T1 post gadolinium sequences and if in the opinion of the PI surgical resection of the multifocal disease is achievable.
. The patient must either be on no steroids or on a stable dose of dexamethasone or equivalent no greater than \> 2 mg a day for at least 5 days prior to lymphodepletion.
Exclusion criteria
. Midline shift greater than 0.5 cm or pending herniation.
. Patients who were previously treated with Bevacizumab. The use of Bevacizumab for edema or radiation necrosis treatments may be allowed with prior approval from the medical monitor
. Anticipated Extent of Resection by volumetric analysis is less than 70%
. Patients with greater than two recurrences of GBM are excluded
. Patients with any contraindications to MRIs
. Treatment with other investigational agents, check point inhibitors and prior immunotherapy such as Vaccine therapy, dendritic cells vaccine within 4 weeks prior to lymphodepletion.
. Prior radiation therapy within 12 weeks of screening MRI unless there is unequivocal histological confirmation of tumor progression.
. Patients with known disease in the posterior fossa, gliomatous meningitis, extracranial disease or multicentric enhancing disease. Multicentric disease is defined as discrete sites of contrast enhancing disease without contiguous T2/FLAIR abnormality.