Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Human CMV pp65-LAMP mRNA-pulsed autologous DCs · 1 trial · 1 indication
OS is defined as the time in months between randomization and death, or last follow-up if alive (Groups 1 and 2). Kaplan-Meier methods will be used to estimate median OS
Percentage of patients with unacceptable toxicity (all Groups)
Change between baseline and nadir before the 2nd cycle of TMZ (Combined Groups 1 and 2, Group 3)
| Arm | Type | Description |
|---|---|---|
| Gr1: DC vaccine (DC pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 1 patients will receive autologous unpulsed DC vaccines administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine as pre-conditioning. |
| Gr2: DC Vaccine (Td pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 2 patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side the day prior to the 4th DC vaccine, which is always given bilaterally at the groin site. |
| Gr3:DC Vaccine+varlilumab(Td pre-conditioning) | EXPERIMENTAL | Patients will receive TMZ at a target dose of 150-200 mg/m\^2/d for 5 days every 4 (+2) weeks for up to 12 cycles. DC vaccines will be administered in equal amounts to both inguinal regions. DC vaccines #1-3 occur every 2 weeks and all subsequent vaccines (up to 10) occur monthly. Group 3 patients will receive the first 3 DC vaccines every 2 weeks, same as Groups 1 and 2, but they will also receive varlilumab intraveneously (IV) 7 days before vaccine #1 and again at the same visit as vaccine #1, as well as 7 days before every DC vaccine except vaccine #2. Prior to the 4th vaccine, patients will receive a single dose of Td toxoid administered to a single side of the groin and saline administered to the contralateral side. |
| Name | Type | Description |
|---|---|---|
| Human CMV pp65-LAMP mRNA-pulsed autologous DCs | BIOLOGICAL | 2x10\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines. |
| Temozolomide | DRUG | Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 4 (+ 2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1) |
| Varlilumab | BIOLOGICAL | Varlilumab is an agonist anti-CD27 monoclonal antibody |
| Td | BIOLOGICAL | A single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally |
| Unpulsed DCs | BIOLOGICAL | Patients in Group I will receive 1 x 10\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine. |
Inclusion Criteria: * Age ≥18 years of age. * Glioblastoma with definitive resection prior to enrollment, with residual radiographic contrast enhancing disease on the post-operative CT or MRI of \<1 cm in maximal diameter in any plane. * Able to receive SOC RT/TMZ for approximately 6 weeks duration...
Human CMV pp65-LAMP mRNA-pulsed autologous DCs is an investigational cell therapy being studied for the treatment of glioblastoma, a type of brain cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Human CMV pp65-LAMP mRNA-pulsed autologous DCs is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate this investigational therapy in patients with glioblastoma.
Human CMV pp65-LAMP mRNA-pulsed autologous DCs is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory agencies and is still being evaluated for safety and efficacy in clinical trials.
Human CMV pp65-LAMP mRNA-pulsed autologous DCs is being studied in a Phase 2 clinical trial registered as NCT03688178. This trial is titled 'DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab' and is actively enrolling patients with glioblastoma in the United States.
No, Human CMV pp65-LAMP mRNA-pulsed autologous DCs is not the same as varlilumab. The clinical trial NCT03688178 is evaluating the combination of these two investigational therapies in patients with glioblastoma. Varlilumab is a separate monoclonal antibody being studied for its potential to enhance the immune response.