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Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma
Phase 1, PHASE2 trial testing Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytes in Cytomegalovirus Positive in 65 participants. Completed in 23 February 2022.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 June 2016 |
| Primary completion | 23 February 2022 |
| Estimated completion | 23 February 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Cytomegalovirus Positive or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants who were treated at the respective dose level without DLT
| Group | Value | 95% CI |
|---|---|---|
| Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6 | 3 | |
| Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7 | 3 | |
| Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7 | 3 | |
| Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8 | 7 |
Descriptive statistics will be used to summarize immunological effect. To evaluate the tumor-mediated immune suppression at the effector location, the markers (interferon, interleukin-2, and tumor necrosis factor alpha, perforin, granzyme B) will be measured for immune responses in the tumor microenvironment rather than in the peripheral blood.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8 | 1 |
Progression-free survival (PFS) is defined as the time from study enrollment until the time of first disease progression, relapse, or death due to disease. Patients who are alive without progression or relapse will be censored at the time of last contact. The point estimate of 6-month progression-free survival (PFS6) will be analyzed. Kaplan-Meier curves will be generated and median survival time will be derived.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8 | 2.5 |
Overall Survival is defined as the time from definitive histological diagnosis until the time of death.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Newly Diagnosed Dose Level 1 x 10^8 | 24 | 13 – 24 |
The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8 | 2.5 |
The number of participants with stable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Newly Diagnosed Dose Level 1 x 10^8 | 3 |
Cox proportional hazard regression will be employed for multivariate analysis.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Newly Diagnosed Dose Level 1 x 10^8 | 5.3 | 4 – 10 |
Progression free survival is defined as time in weeks from start of study treatment to first documentation of objective tumor progression or up to death due to any cause, whichever occurs first.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Newly Diagnosed Dose Level 1 x 10^8 | 19 | 9 – 20 |
Time frame: from the first dose through 30 days after the completion of study treatment, up to 4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase II: Newly Diagnosed … | Phase II: Recurrent Gliobl… |
|---|---|---|---|---|---|---|---|
| Confusion | Psychiatric disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Surgical and medical procedures, other-removal of facial cyst | Surgical and medical procedures | — | — | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — | — | — |
| Cognitive Disturbance | Psychiatric disorders | — | — | — | — | — | — |
| Reaction | System | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase I: Recurrent Gliobla… | Phase II: Newly Diagnosed … | Phase II: Recurrent Gliobl… |
|---|---|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Nausea | General disorders | — | — | — | — | — | — |
| Weight loss | Investigations | — | — | — | — | — | — |
| Memory impairment | Nervous system disorders | — | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Fatigue | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Seizure | Nervous system disorders | — | — | — | — | — | — |
| Concentration impairment | Nervous system disorders | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Decreased platelet count | Investigations | — | — | — | — | — | — |
| Decreased lymphocyte count | Investigations | — | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Cognitive Disturbance | Nervous system disorders | — | — | — | — | — | — |
| Confusion | Psychiatric disorders | — | — | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — | — | — |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Malaise | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Lethargy | Nervous system disorders | — | — | — | — | — | — |
| Decreased neutrophil count | Investigations | — | — | — | — | — | — |
| Mucositis | Gastrointestinal disorders | — | — | — | — | — | — |
Most-reported serious reactions: Confusion, Headache, Muscle Weakness, Surgical and medical procedures, other-removal of facial cyst, Somnolence, Cognitive Disturbance.
Data from ClinicalTrials.gov NCT02661282 adverse events section.
This phase I/II trial studies the side effects and best dose of autologous cytomegalovirus (CMV)-specific cytotoxic T cells when given together with temozolomide and to see how well they work in treating patients with glioblastoma. Autologous CMV-specific cytotoxic T cells may stimulate the immune system to attack specific tumor cells and stop them from growing or kill them. Drugs used in chemotherapy, such as temozolomide, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving autologous CMV-specific cytotoxic T cells with temozolomide may be a better treatment for patients with glioblastoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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