NCT03984968Fut, nem toboroz1/2. fázis
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia
Evaluation of the Safety and Efficacy of CD19 CAR-T Combined With Autologous T Cells Engineered to Express CD19 (CD19+ Feeding T Cells, FTCs) for Consolidation Treatment for Acute Lymphoblastic Leukemia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 7.
Rövid összefoglaló (regiszter, angolul)
This is a single-arm, open-label, single-center, phase I/II study to determine the safety and efficacy of CD19 CAR-T(ssCART-19) combined with autologous T cells engineered to express CD19, namely CD19+ feeding T cells (FTCs), as consolidation therapy in patients diagnosed with de novo Philadelphia chromosome-positive CD19+ B-ALL. The study will contain the following sequential phases: screening, lymphocyte apheresis, induction, and consolidation chemotherapies combined with tyrosine kinase inhibitors. Once in complete response, patients will receive two to four cycles of ssCART-19s, namely one cycle of ssCART-19 infusion (CAR-T1) followed by one to three cycles of ssCART-19 and CD19+ FTC infusion (CAR-T2-4). The role of CD19+ FTCs is to mimic leukemia cells. Therefore, they are expected to stimulate in vivo expansion and persistence of ssCART-19. Considering the limited number of lymphocytes obtained by a single apheresis from patients and cost-efficacy, in addition to safety, we will explore the range of biologically active doses of FTCs in a phase I study. Based on preclinical data, FTCs' stimulation of ssCART-19 at a ratio of 1:1 could achieve the best activation response, so a 5×10\^6/kg dosage of FTCs was set as the initial dosage in the study, and lower doses were also evaluated. In phase I, FTCs will be administered at the dose of 5×10\^6/kg, 3.25×10\^6/kg, or 2×10\^6/kg two hours after ssCART-19 infusion on day 1 and once again administered at the same dose on day 8. After ssCART-19 and FTCs infusion, adverse events (AEs) as the primary endpoints will be recorded for 6 months; efficacy as the secondary endpoint will be assessed by detecting molecular response for 6 months, PFS, and OS for 2 years. In phase II, we will expand the study at optimal biological doses of FTCs and further evaluate the efficacy and safety of the innovative combination therapy of ssCART-19 and FTCs. The primary endpoint was the complete molecular response (CMR). The secondary endpoints were RFS, OS, and adverse events (AEs) of the patients.
- Állapot (regiszter)
- Fut, nem toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tervezett)
- Első benyújtás
- 2019. jún. 11.
- Kezdés
- 2017. júl. 10.
- Elsődleges befejezés
- 2025. júl. 20.
- Fő szponzor
- The First Affiliated Hospital of Soochow University
- Betegségek
- Akut limfoid leukémia (ALL), Gyermekkori daganatok
- NCT-szám
- NCT03984968
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 40
- 2017. júl. 10. és az elsődleges befejezés (2025. júl. 20.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period.
- Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies.
- Ongoing treatment with chronic immunosuppressants
Más betegség
- Significant comorbid conditions or diseases which, in the judgment of the investigator, would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
- Known human immunodeficiency virus (HIV) positivity
- Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
- Subjects with second malignancies in addition to ALL
Laborértékek
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 × upper limit of normal (ULN) and direct bilirubin > 1.5 × ULN
- Inadequate renal function defined by serum creatinine > 1.6 mg/dL
- International ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN
- Left ventricular ejection fraction < 50%
Egyéb
- Pregnant or lactating women, or subjects refusing to take effective contraception measures
- Other contraindications that are considered inappropriate to participate in this trial
Kiket keres a vizsgálat
- 15-65 years of age at the time of signing informed consent
- Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL
- Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study
- Ability and willingness to adhere to the study visit schedule and all protocol requirements
- Voluntarily sign informed consent forms
Életkor a regiszterben: 15 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The First Affliated Hospital of Soochow University | Suzhou | Kína | Ismeretlen állapot |
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