Clinical trial · Interventional
Cellular Immunotherapy Study for Brain Cancer
A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Mixed Glioma | Anaplastic Oligoastrocytoma | ALIAS | 0.90 |
| Anaplastic Oligodendroglioma | Anaplastic Oligodendroglioma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliomas | Glioma | ALIAS | 0.90 |
| Malignant Meningioma | Grade 3 Meningioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alloreactive CTL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- alloreactive CTL arm
- interventionNames
- Drug: alloreactive CTL
Primary outcomes (1)
- measure
- Number of patients with adverse events as a measure of safety and tolerability
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA To participate in this clinical trial, patients must meet the following eligibility criteria: 1. Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI. 2. Tumor must be amenable to resection, and surgical resection must be clinically indicated. 3. Age at least 18 years. 4. Karnofsky performance scale score \>60. 5. Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%. 6. Adequate renal function, with creatinine less than two times the upper limit. 7. Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin \< 2x upper limit of normal. 8. Patients must have an expected survival of at least three months. 9. Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C. 10. Patients must sign an informed consent. EXCLUSION CRITERIA Patients will be excluded from the trial if the patients: 1. have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors. 2. have prior tumor resections where the ventricles were extensively breached. 3. are pregnant or breast-feeding women. 4. are females of child-bearing potential unable or unwilling to practice adequate birth control methods. 5. have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker). 6. have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 7. have concurrent systemic infection. 8. have any clinically significant, uncontrolled medical illness, as determined by the investigators. 9. are unwilling or unable to comply with procedures required in this protocol.
References
Publications (4)
- BACKGROUNDHickey MJ, Malone CC, Erickson KL, Jadus MR, Prins RM, Liau LM, Kruse CA. Cellular and vaccine therapeutic approaches for gliomas. J Transl Med. 2010 Oct 14;8:100. doi: 10.1186/1479-5876-8-100. PMID 20946667
- BACKGROUNDHickey MJ, Malone CC, Erickson KE, Gomez GG, Young EL, Liau LM, Prins RM, Kruse CA. Implementing preclinical study findings to protocol design: translational studies with alloreactive CTL for gliomas. Am J Transl Res. 2012;4(1):114-26. Epub 2012 Jan 10. PMID 22347526
- RESULTKruse CA, Cepeda L, Owens B, Johnson SD, Stears J, Lillehei KO. Treatment of recurrent glioma with intracavitary alloreactive cytotoxic T lymphocytes and interleukin-2. Cancer Immunol Immunother. 1997 Oct;45(2):77-87. doi: 10.1007/s002620050405. PMID 9390198
- RESULTKruse, C.A., Rubinstein, D. (2001) Cytotoxic T Lymphocytes Reactive to Patient Major Histocompatibility Proteins for Therapy of Recurrent Primary Brain Tumors, in Brain Tumor Immunotherapy, eds. L.M. Liau, D.P. Becker, T.F. Cloughsey, and D. Bigner, Humana Press, pp. 149-170