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New treatment option for Recurrent Gliosarcoma
Official title Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM
ClinicalTrials.gov ID: NCT04991870
What this study is testing
What is Cord Blood-derived Expanded Allogeneic Natural Killer Cells?
Cord Blood-derived Expanded Allogeneic Natural Killer Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent gliosarcoma.
Also referred to as Allogeneic CB-derived Ex vivo-expanded NK Cells, CB-derived Expanded Allogeneic NK Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial is to find out the best dose, possible benefits and/or side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood [CB]-NK-TGF-betaR2-/NR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-/NR3C1- cells are genetically changed immune cells that may help to control the disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Signed and dated informed consent.
- Male or female participants aged ≥ 12 years on the day of signing informed consent.
- Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or...
- Karnofsky Performance Score (KPS) of \>70 at trial entry. Lansky \>70 at trial entry for patients less than 16.
- Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.
You likely can't join if
- Has received prior therapy with Gliadel or bevacizumab.
- Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.
- Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4...
- Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.
- Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2 antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HbsAg...
- Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.
See the full eligibility criteria
Who can join
- Signed and dated informed consent.
- Male or female participants aged ≥ 12 years on the day of signing informed consent.
- Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent...
- Karnofsky Performance Score (KPS) of \>70 at trial entry. Lansky \>70 at trial entry for patients less than 16.
- Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.
- A baseline brain MRI with Advance Brain Tumor Imaging (ABTI) must be obtained no more than 30 days prior to study registration
- Patients having undergone recent surgery are eligible so long as they are at least 3 weeks from resection or at least 1 week from stereotactic biopsy and recovered from any operative or perioperative complications.
- Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10°9/L with absolute neutrophil count (ANC) ≥ 1.5 x 10°9/L, lymphocyte count ≥ 0.5 x 10°9/L, platelet count ≥ 100 x 10°/L, and Hgb ≥ 9 g/ dL...
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 x ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5 10. Adequate renal function defined creatinine ≥ 1.5 X upper limit of...
What rules you out
- Has received prior therapy with Gliadel or bevacizumab.
- Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.
- Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is...
- Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.
- Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2 antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients...
- Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.
- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0.
- Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If participant received major surgery (other than craniotomy), they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has had prior radiation therapy less than 12 weeks prior to study registration, unless RANO criteria for early progression are met.
- Has had prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody within the last three months prior to study registration -.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include but are not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical...
- Has known gliomatous cerebri, extracranial disease, or tumor localized primarily to the brainstem or spinal cord.
- Brain midline shift greater than 0.5 cm or pending herniation seen on baseline MRI ABTI.
- Tumors larger than 5 cm at greatest diameter
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive...
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the participant's participation, assessment of experimental treatment toxicity or increase the participant's risk of...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Has a contraindication for undergoing MRIs.
- Has evidence of bleeding diathesis or coagulopathy.
- Is on full dose anticoagulants or antiplatelet therapy that cannot be held.
- Has significant hemorrhage on baseline MRI ABTI defined as \>1 cm diameter of acute blood.
- Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
- Has multicentric disease. Subject has multicentric GBM, defined as discrete sites of contrast enhancing disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.