Adrenocortical carcinoma · NCT04119024
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors
- Status
- RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE1
- Sponsor
- Anusha Kalbasi
- Registry records
- CTGOV NCT04119024 (RECRUITING)Registry last updated 2026-03-17
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · condition · confidence 0.85 | Histologically confirmed malignancy that is considered surgically incurable with either: Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis | "Histologically confirmed malignancy that is considered surgically incurable with either:" | |
| inclusion inclusion · stage extent · confidence 0.90 | Stage IV melanoma including patients with known brain metastases | "Stage IV melanoma including patients with known brain metastases" | |
| inclusion inclusion · stage extent · confidence 0.85 | Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible | "Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible" | |
| inclusion inclusion · biomarker · confidence 0.97 | Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay [IHA] H-Score >= 50 in at least 10% of the total tumor specimen and in at least two high-power fields) | "Confirmed IL13Ralpha2 tumor expression by immunohistochemistry" | |
| inclusion inclusion · age sex · confidence 0.95 | Age greater than or equal to 18 years old and less than 75 years old | "Age greater than or equal to 18 years old and less than 75 years old" | |
| inclusion inclusion · performance status · confidence 0.98 | Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 | "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1" | |
| inclusion inclusion · lesion burden · confidence 0.95 | A minimum of one measurable lesion defined as: Meeting the criteria for measurable disease according to RECIST, OR skin lesion(s) selected as non-completely biopsied target lesion(s) measurable by color photography with a ruler | "A minimum of one measurable lesion defined as:" | |
| inclusion inclusion · lab value · confidence 0.97 | Absolute neutrophil count (ANC) >= 1 x 10^9 cells/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Absolute neutrophil count (ANC) \>= 1 x 10\^9 cells/L" | |
| inclusion inclusion · lab value · confidence 0.97 | Platelets >= 75 x 10^9/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Platelets \>= 75 x 10\^9/L" | |
| inclusion inclusion · lab value · confidence 0.97 | Hemoglobin >= 9.5 g/dL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Hemoglobin \>= 9.5 g/dL" | |
| inclusion inclusion · lab value · confidence 0.97 | Aspartate and alanine aminotransferases (AST, ALT) =< 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Aspartate and alanine aminotransferases (AST, ALT) =\< 2.5 x upper limit of normal (ULN)" | |
| inclusion inclusion · lab value · confidence 0.97 | Total bilirubin =< 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Total bilirubin =\< 2 x ULN (except patients with documented Gilbert's syndrome)" | |
| inclusion inclusion · lab value · confidence 0.95 | Creatinine < 2 mg/dL (or a glomerular filtration rate > 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) | "Creatinine \< 2 mg/dL (or a glomerular filtration rate \> 45)" | |
| inclusion inclusion · prior therapy · confidence 0.93 | Patients with melanoma must have progressed following >= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent | "Patients with melanoma must have progressed following \>= 1 line of systemic therapy" | |
| inclusion inclusion · condition · confidence 0.90 | Patients with melanoma must have progressed following systemic therapy | "Patients with melanoma must have progressed following" | |
| inclusion inclusion · logistics · confidence 0.30 | Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis) | "Must be willing and able to accept at least one leukapheresis procedure" | |
| inclusion inclusion · consent · confidence 0.30 | Must be willing and able to provide written informed consent | "Must be willing and able to provide written informed consent" | |
| exclusion exclusion · logistics · confidence 0.30 | Inability to purify >= 1 x 10^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis) | "Inability to purify \>= 1 x 10\^7 T cells from leukapheresis product" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine | "Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine" | |
| exclusion exclusion · washout · confidence 0.95 | Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol | "Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol" | |
| exclusion exclusion · condition · confidence 0.95 | Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion as long as under control | "Clinically active brain metastases." | |
| exclusion exclusion · washout · confidence 0.93 | Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including adrenal insufficiency physiologic replacement, or inhaled or topical steroids at standard doses | "Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion | "Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments | "Hepatitis B or C seropositivity with evidence of ongoing liver damage" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol | "Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol" | |
| exclusion exclusion · organ function · confidence 0.95 | A Tiffeneau-Pinelli index < 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability | "A Tiffeneau-Pinelli index \< 70% of the predicted value." | |
| exclusion exclusion · organ function · confidence 0.90 | History of clinically significant ECG abnormalities, symptoms of cardiac ischemia or arrhythmias and LVEF < 45% on a cardiac stress test | "have a left ventricular ejection fraction (LVEF) \< 45% on a cardiac stress test" | |
| exclusion exclusion · organ function · confidence 0.30 | Patients with ECG results of any conduction delays (PR interval > 200 ms, QTC > 480 ms), sinus bradycardia, sinus tachycardia will be evaluated by a cardiologist prior to starting the trial | "Patients with ECG results of any conduction delays (PR interval \> 200 ms, corrected QT (QTC) \> 480 ms), sinus bradycardia (resting heart rate \< 50 beats per minute), sinus tachycardia (HR \> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial." | |
| exclusion exclusion · comorbidity · confidence 0.93 | Patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy, ventricular tachycardia, 3rd degree heart block will be excluded unless cleared by a cardiologist | "Patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as \> 20 ventricular premature complex \[PVC\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist" | |
| exclusion exclusion · pregnancy contraception · confidence 0.97 | Pregnancy or breast-feeding. | "Pregnancy or breast-feeding." | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. | "Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards." | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | All female patients with reproductive potential must have a negative pregnancy test (serum/urine) at screening and again within 14 days from starting the conditioning chemotherapy. | "All female patients with reproductive potential must have a negative pregnancy test (serum/urine) at screening and again within 14 days from starting the conditioning chemotherapy." | |
| exclusion exclusion · comorbidity · confidence 0.93 | A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study | "A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study" |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
Inclusion Criteria: * Histologically confirmed malignancy that is considered surgically incurable with either: * Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis * Stage IV melanoma including patients with known brain metastases * Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible * Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay \[IHA\] H-Score \>= 50 in at least 10% of the total tumor specimen and in at least two high-power fields) * Age greater than or equal to 18 years old and less than 75 years old * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * A minimum of one measurable lesion defined as: * Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), OR * Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s) * Absolute neutrophil count (ANC) \>= 1 x 10\^9 cells/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Platelets \>= 75 x 10\^9/L (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Hemoglobin \>= 9.5 g/dL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Aspartate and alanine aminotransferases (AST, ALT) =\< 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Total bilirubin =\< 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Creatinine \< 2 mg/dL (or a glomerular filtration rate \> 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy) * Patients with melanoma must have progressed following \>= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent * Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis) * Must be willing and able to provide written informed consent Exclusion Criteria: * Inability to purify \>= 1 x 10\^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis) * Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine * Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol * Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment * Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including patients with primary or secondary adrenal insufficiency who require physiologic replacement with steroids, or patients on inhaled or topical steroids at standard doses * Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist * Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * A Tiffeneau-Pinelli index \< 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability * Patients will be excluded if they have a history of clinically significant electrocardiography (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) \< 45% on a cardiac stress test (stress thallium, stress multigated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test) * Patients with ECG results of any conduction delays (PR interval \> 200 ms, corrected QT (QTC) \> 480 ms), sinus bradycardia (resting heart rate \< 50 beats per minute), sinus tachycardia (HR \> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial. Patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as \> 20 ventricular premature complex \[PVC\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist * Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study * A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study
Routes in: how this trial is reached and paid for
US trials at ordinary hospitals: routine care is billed
In the US a sponsor funds the study drug and study-specific scans, but the routine care around them is billed to insurance. Without US cover that bill falls on you.
Cost is documented as the barrier that stops roughly 45 percent of US patients joining trials, before any question of being a non-resident. Eligibility on paper does not make a US site reachable. One email to the study coordinator asking what a non-resident without US insurance would be billed settles it either way.
Verify with: The study coordinator listed on the registry record
Ask first; potentially very high
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Sites (3)
United States
- City of Hope, Duarte
- UCLA / Jonsson Comprehensive Cancer Center, Los Angeles
- Stanford Cancer Institute, Stanford