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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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).

Locations
United States
California
City of Hope
Recruiting
Duarte
University of California, Irvine
Recruiting
Irvine
Florida
Miami Cancer Institute at Baptist Health
Not yet recruiting
Miami
Illinois
Northwestern University
Recruiting
Chicago
New Jersey
Hackensack
Recruiting
Hackensack
Texas
MD Anderson
Recruiting
Houston
Contact Information
Primary
Kevin Berth, B.S
kevin.berth@Celularity.com
908-373-1898
Backup
Mark Awadalla, B.S
Mark.Awadalla@Celularity.com
908-485-4569
Time Frame
Start Date: March 8, 2022
Estimated Completion Date: May 2024
Participants
Target number of participants: 66
Treatments
Experimental: Phase 1Surgical rGBM CYNK-001 infusion ( IV and IC) in combination with IL-2
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 Phase 1.
Experimental: Phase IIa Surgical rGBM CYNK-001 at MPD IV and IC
To 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
Sponsors
Leads: Celularity Incorporated

This content was sourced from clinicaltrials.gov

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