D2C7-IT + 2141-V11 Combination Post-resection in rGBM

Conditions

• Recurrent Glioblastoma IDH Wildtype

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D2C7-IT — DRUG
  D2C7-IT will be dosed at 166,075 ng in 36 mL.
• 2141 V11 — DRUG
  2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.

Study Details

The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.

Key Dates

Start date

Mar 17, 2025

Status verified

Oct 2025

Primary completion

Jan 31, 2029

Completion

Jan 31, 2030

Study Design

Enrollment

46 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: D2C7-IT + 2141-V11
  Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by an 2141-V11 infusion over 7 hours. This is followed by injections of 2141-V11 (2mg) in the cervical perilymphatic (CPLI) subcutaneous area ipsilateral to the tumor at weeks 2, 4, 7, 10 and then every 3 weeks until week 49. After week 49 (equivalent of 1 year of every 3 weeks CPLI of 2141-V11), patients who have completed 1 year of CPL subcutaneous injections of 2141-V11 at 2 mg every 3 weeks, who benefit from the therapy, and desire to continue on therapy, will receive CPLI of 2141-V11 at 2 mg every 4-6 weeks.

Primary Outcome Measure

Primary Outcome - Safety [ Time Frame: 5 years ]

Central Contacts

• Annick Desjardins, MD
  919-684-5301
  [email protected]
• Stevie Threatt
  919-684-5301
  [email protected]

Locations (1)

Find similar trials in Durham, NC