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Astrocytoma, Grade IVPhase 1/2CYNK001GBM02NCT05218408

CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type

A Phase 1/2 study testing CYNK-001 systemic and Intra cavity administration in people with Astrocytoma, Grade IV and Glioblastoma, run by Celularity Incorporated.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CYNK-001 systemic and Intra cavity administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2021to 23 Oct 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • 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.
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  • 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.
  • NOTE: Multicentric disease with no demonstrated ventricle communication at the time of screening is excluded.
  • 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.
  • Karnofsky performance status (KPS) ≥ 60
  • Have washout periods for prior therapies defined as at five half-lives or (4 weeks) prior to the administration of lymphodepletion whichever is shorter
  • Demonstrate at screening adequate organ function by laboratory values as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L (patient needs to have a minimum of 70 x10^9/L to undergo resection)
  • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2 .5 the upper limit of normal (ULN)
  • Calculated creatinine clearance ≥ 45.0 mL/minute as estimated by Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x ULN, unless due to Gilbert's syndrome
  • Total albumin ≥ 3.0 g/dL (30 g/L)
  • Prothrombin Time (PT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants
  • activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Adequate coagulation function defined as INR ≤ 1.5 x ULN, unless the patient is receiving anticoagulant therapy with PT or a PTT/PTT is within therapeutic range.
  • Patients must agree to use a highly effective method of contraception if procreative potential exists from the start of the study until one year after the completion of lymphodepletion for females and 4 months after completion of lymphodepletion for males.
  • A Female of Childbearing Potential (FCBP) is defined as: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).

Who cannot join

  • 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.
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  • 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.
  • NOTE: Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) may be included.
  • Patients with concurrent use of tumor treating fields (TTF) or laser interstitial thermal therapy (LITT) is excluded. Prior use of TTF or LITT is allowed prior to signing the ICF
  • Patients with current Carmustine wafers. (Patients that agree to remove the Carmustine wafers at the time of tumor resection during the study are allowed in the study)
  • Patents who are receiving systemic steroid therapy > 2 mg of dexamethasone or equivalent total dose per day or any other form of immunosuppressive therapy within 5 days of lymphodepletion.
  • Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients requiring physiological doses of steroids (i.e., adrenal insufficiency or hypopituitarism) not to exceed equivalent of dexamethasone 2 mg will not be excluded from the study.
  • Patients with history of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
  • Active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy.
  • Any other organ dysfunction (CTCAE Version 5.0 Grade 3 or greater) that will interfere with the administration of the lymphodepletion regimen, rhIL-2, CYNK-001 or the surgical resection as outlined.
  • Known hypersensitivity to cyclophosphamide, fludarabine, Mesna or rhIL-2.
  • Have active or clinically significant cardiac disease including:
  • History or presence of serious uncontrolled cardiac arrhythmias.
  • Clinically significant resting bradycardia.
  • Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) <50% or multiple gated acquisition scan (MUGA) <45%.
  • Any of the following within 6 months prior to the start of the study treatments: myocardial infarction (MI), severe/unstable angina, congestive heart failure (CHF), transient ischemic attack (TIA).
  • Patients with an SaO2 ≤ 92% on room air.
  • Pulmonary Function Tests may be performed during screening for patients with SaO2 ≤ 92% on room air and based on the clinical judgment of the treating physician, patients with an FEV1 ≥ 50% of predicted and DLCO (corrected) of ≥ 40% of predicted may be enrolled.
  • Has any form of primary immunodeficiency, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
  • Patients with history of human immunodeficiency virus (HIV) infection must have undetectable HIV ribonucleic acid (RNA).
  • Known active infection with hepatitis B, hepatitis C or other viral infections requiring systemic therapy.
  • Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
  • Is Pregnant or breastfeeding.
  • Received a live vaccine within 30 days prior to lymphodepletion (Day -5).
  • Any other clinically significant medical disease or condition that, in the Principal Investigator's opinion, may interfere with protocol adherence or the patient's ability to provide informed consent.

About this study

Official title: A Phase I/IIa Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001in Combination With Recombinant Human Interleukin-2 in Adults With Recurrent Resection Eligible IDH1 Wild-type Glioblastoma

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)

Read the detailed description

This Phase 1/2a, open-label, multicenter, non-randomized study was designed to evaluate the safety, feasibility, and preliminary efficacy of CYNK-001 in combination with recombinant human interleukin-2 (rhIL-2) in adults with recurrent resection-eligible IDH1 wild-type glioblastoma (GBM). The Phase 1 portion was intended to assess the safety and feasibility of intravenous and intracavitary administration of CYNK-001 following tumor resection and to determine the maximum tolerated dose (MTD) and recommended Phase 2a dose (RP2D). The Phase 2a portion was intended to evaluate efficacy and safety, including progression-free survival at 6 months (PFS6M).

The study was withdrawn prior to enrollment, and no participants were enrolled or treated.

Being tested
CYNK-001 systemic and Intra cavity administration
Keywords
Interleukin-1, Cyclophosphamide, Fludarabine, immunosuppressive agents, immunological factor, IDH wild type, Surgical GBM, Natural Killer, Cellular Therapy, Allogeneic, Allogeneic stem cell, Ommaya catheter
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYNK-001 systemic and Intra cavity administrationBiological

    CYNK-001 administered intravenously and intracavitarily in combination with subcutaneous recombinant human IL-2 following lymphodepleting chemotherapy. The study was designed to evaluate escalating dose levels of CYNK-001 in Phase 1 and the recommended dose in Phase 2a.

    The study was withdrawn prior to enrollment and no participants were treated.

Study groups in NCT05218408
Study groupRoleWhat they receive
Phase 1Surgical rGBM CYNK-001 infusion ( IV and IC) in combination with IL-2ExperimentalPhase 1 dose escalation will utilize a 3+3 dose escalation design and will evaluate safety, feasibility, and preliminary efficacy of four cohort dose levels of CYNK-001 administered after a 6M IU subcutaneous dose of rhIL-2 for both IV and IC cycles. Up to 21 patients will be enrolled over 4 dosing cohorts in Phase 1.
Receives: Biological: CYNK-001 systemic and Intra cavity administration
Phase IIa Surgical rGBM CYNK-001 at MPD IV and ICExperimentalTo evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM at maximum tolerated dose for IV and IC per Phase 1 outcome. No patients staggering will be implemented in phase 2a. DMC will review the phase 2a entirely
Receives: Biological: CYNK-001 systemic and Intra cavity administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I-Number of patients experience Dose limiting toxicity (DLT)

    Defined as the maximum dose safely administered intravenously or Intracavitary for the treatment of patients with GBM

    Measured: 42 days

  2. To establish maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D)

    Defined as the number of patients experience Adverse Events and severity

    Measured: 42 days

  3. Phase IIa CYNK-001 efficacy

    To evaluate CYNK-001 efficacy post tumor resection and survival within PFS6 Month

    Measured: 6 Months

Secondary outcomes (2)

  1. Phase 1-Progression free survival at 6 Months

    is defined as the time from the tumor resection to the date of first documented disease progression determined in accordance with RANO (and iRANO) or death due to any reason, whichever occurs first

    Measured: 6 Months

  2. Overall survival phase I and IIa

    is defined as the time from the tumor resection until the date of death at 6,9 and 12 months

    Measured: 6,9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study startSep 2021 (estimated)
  3. Primary completion23 Oct 2021
  4. Study completion23 Oct 2021

Why it stopped: No participants were enrolled. Study was withdrawn prior to treatment initiation.

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The study will contain two phases for the following objectives •The Phase 1 Dose Escalation will utilize a 3+3 dose escalation design and will evaluate safety, feasibility, and preliminary efficacy of four cohort dose levels of CYNK-001 administered after a 6M IU subcutaneous dose of rhIL-2 for both IV and IC cycles. Up to 21 patients will be enrolled over 4 dosing cohorts in Phase1 and 45 patients enrolled for phase IIa. Cohort 4 will be the safety run for Phase IIa. Cohort 4 in its entirety will be reviewed by the DMC prior to starting Phase 2a portion of this study. Phase 2a will continue to explore efficacy and safety of CYNK-001 in combination with rhIL2 in patients with recurrent resection eligible IDH1 wild-type glioblastoma.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218408
Sponsor's protocol ID
CYNK-001-GBM-002
Acronym
CYNK001GBM02
Status last verified
Jun 2026
First submitted
18 Jan 2022
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CYNK-001 systemic and Intra cavity administration in people with Astrocytoma, Grade IV and Glioblastoma, run by Celularity Incorporated.

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 24 inclusion and 31 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: withdrawn, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I-Number of patients experience Dose limiting toxicity (DLT) (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218408.

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 8 Jun 2026.

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