Status:
WITHDRAWN
CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type
Lead Sponsor:
Celularity Incorporated
Conditions:
Astrocytoma, Grade IV
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
- 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).
Exclusion
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05218408
Start Date
March 8 2022
End Date
May 1 2024
Last Update
February 16 2023
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