NCT02028455Fut, nem toboroz1/2. fázis
A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-02: A Phase 1/2 Feasibility and Safety Study of CD19-CAR T Cell Immunotherapy for CD19+ Leukemia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 6.
Rövid összefoglaló (regiszter, angolul)
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well as to determine the efficacy. The phase 1 cohort is restricted to those patients who have already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all patients regardless of having a history of HCT.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 167 (tényleges)
- Első benyújtás
- 2014. jan. 3.
- Kezdés
- 2014. febr. 11.
- Elsődleges befejezés
- 2021. aug. 10.
- Fő szponzor
- Seattle Children's Hospital
- Betegségek
- Akut limfoid leukémia (ALL), Gyermekkori daganatok
- NCT-szám
- NCT02028455
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Bevont résztvevők: 167
- 2014. febr. 11. és az elsődleges befejezés (2021. aug. 10.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Kiket keres a vizsgálat
- Patients must be ≥12 months of age and <27 years of age at the time of study enrollment.
- Must be ≥10kg
- Confirmed CD19+ leukemia recurrence defined as ≥0.01% disease in the marrow or isolated extramedullary disease following allogeneic HCT. [N.B. Study closed to enrollment of leukemia subjects]
- OR
- No prior history of allogeneic HCT (one of the following)
- 2nd or greater relapse, with or without extramedullary disease (isolated extramedullary disease is eligible)
- 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blast disease, with or without extramedullary disease
- Primary Refractory as defined as having M2 or M3 marrow after induction
- Subject has indication for HCT but has been deemed ineligible
- OR
- CD19+ Non-Hodgkin Lymphoma (NHL) refractory or relapsed with no known curative therapies available [N.B. Study remains open to enrollment of lymphoma subjects]
- Patients with CNS involvement are eligible provided that they are asymptomatic and in the opinion of the study PI have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion. Patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization.
- Patients must have a Lansky performance status score of ≥50 or a Karnofsky score of ≥ 50 for patients ≥16 years of age.
- Life Expectancy of >8 weeks
- Patients must be free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment.
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
- It must be at least 7 days since last chemotherapy was administered (this does not include intrathecal chemotherapy or maintenance chemotherapy)
- No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment.
- No prior genetically modified cell therapy that is still detectable or virotherapy allowed.
- Normal serum creatinine based on age/gender
- Total bilirubin </3x ULN OR conjugated bilirubin </2mg/dl
- ALT </5X ULN
- SF of >28% by ECHO or EF >50% by MUGA
- ALC of >/= 100 cells/ul
- Pulse ox >/= 90% on room air
- Patient must have documented negative HIV antigen and antibody, Hepatitis B surface antigen, and Hepatitis C antibody within 3 months prior to enrollment. For patient with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible.
- Patients must NOT have active clinically significant CNS dysfunction (including but not limited to such as uncontrolled seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- Must agree to highly effective contraception during and for 12 months after T cell infusion.
- Patients must be able to tolerate apheresis procedure, including placement of temporary apheresis line if required.
- Patients must NOT have an active malignancy other than CD19+ leukemia.
- Patients must NOT have an active severe infection defined as:
- A positive blood culture within 48 hours of study enrollment
- A fever above 38.2 C AND clinical signs of infection within 48 hours of study enrollment
- Patients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy. Patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trial.
- Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion.
Életkor a regiszterben: 1 év – 26 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | Egyesült Államok | Ismeretlen állapot |
| Children's Hospital Oakland | Oakland | Egyesült Államok | Ismeretlen állapot |
| Seattle Children's Hospital | Seattle | Egyesült Államok | Ismeretlen állapot |
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