ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT06542250 (TITANium) के लिए बी-सेल घातकता वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
एस्ट्राजेनेकाA Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (TITANium) चरण I, चरण II 174
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06542250 (TITANium) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन बी-सेल घातकता से जुड़ा हुआ है और यह एक चरण I चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 18 सितंबर 2024 को हुई थी, और इसमें कुल 174 प्रतिभागियों के नामांकन की योजना है। एस्ट्राजेनेका इस परीक्षण का नेतृत्व कर रहे हैं और इसके 14 फ़रवरी 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 27 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
आधिकारिक शीर्षक
A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)
स्वास्थ्य स्थितियां
बी-सेल घातकताअन्य अध्ययन आईडी
- TITANium
- D9960C00001
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-09-18
अंतिम अद्यतन प्रकाशित
2026-03-27
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-02-14
नामांकन (अनुमानित)
174
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
चरण II
चरण II
स्थिति
भर्ती जारी
प्रमुख शब्द
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
अनुक्रमिक
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकModule 1: AZD5492 Monotherapy AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies. | AZD5492 CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Frequency of dose limiting toxicities (DLTs). | DLTs are dose-limiting toxicities as defined in the study protocol. | Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks). |
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events. | Incidence and severity of AEs, AESIs, and SAEs | Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy. |
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events. | SAEs/AEs leading to discontinuation of AZD5492. | Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy. |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Overall Response Rate (ORR) | The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
Complete Response Rate (CR Rate) | The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
Duration of Response (DoR) | The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
Progression-free Survival (PFS) | The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
Overall Survival (OS) | The time from the date of first dose until date of death due to any cause. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
Pharmacokinetics of AZD5492: serum concentration of study drug | Maximum observed serum concentration of AZD5492. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax). | Maximum observed plasma concentration of AZD5492. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC). | Area under the plasma concentration-time curve. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
Pharmacokinetics of AZD5492: apparent clearance | The volume of plasma from which the study drug is completely removed per unit time. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
Pharmacokinetics of AZD5492: Half-life (t 1/2) | Terminal elimination half-life. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
To determine the immunogenicity of AZD5492 | The number of participants who develop ADAs measured in serum. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
To determine the immunogenicity of AZD5492 | The percentage of participants who develop ADAs measured in serum. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
≥18 years of age;
Histologically documented CD20+ mature B-cell neoplasm
- Large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
ECOG performance status of ≤ 2 (< 2 in EU countries).
The above is a summary, other inclusion criteria details may apply.
- Any neoplasm histology not specified in the IC section;
- Active CNS involvement in lymphoma;
- CNS pathology including but not limited to any history of seizure disorder/epilepsy;
- Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
- History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
- Active and uncontrolled infections;
- Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions
The above is a summary, other exclusion criteria details may apply.
एस्ट्राजेनेका772 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिएअध्ययन केंद्रीय संपर्क
संपर्क: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
29 10 देशों में अध्ययन स्थान
California
Research Site, La Jolla, California, 92093, United States
भर्ती जारी
Massachusetts
Research Site, Boston, Massachusetts, 02215, United States
वापस लिया गया
New Jersey
Research Site, Hackensack, New Jersey, 07601, United States
भर्ती जारी
New York
Research Site, New York, New York, 10021, United States
भर्ती जारी
Research Site, New York, New York, 10029, United States
भर्ती जारी
North Carolina
Research Site, Charlotte, North Carolina, 28203, United States
भर्ती जारी
Research Site, Winston-Salem, North Carolina, 27157, United States
भर्ती जारी
Texas
Research Site, Houston, Texas, 77030, United States
भर्ती जारी
Washington
Research Site, Seattle, Washington, 98109, United States
भर्ती जारी
Research Site, Melbourne, 3000, Australia
भर्ती जारी
Research Site, Nedlands, 6009, Australia
भर्ती जारी
Alberta
Research Site, Calgary, Alberta, T2N 5G2, Canada
भर्ती जारी
Ontario
Research Site, Toronto, Ontario, M5G 2M9, Canada
भर्ती जारी
Quebec
Research Site, Montreal, Quebec, H3T 1R2, Canada
भर्ती जारी
Research Site, Hangzhou, 310003, China
भर्ती जारी
Research Site, Shanghai, 200025, China
भर्ती जारी
Research Site, København Ø, 2100, Denmark
भर्ती जारी
Research Site, Pessac, 33604, France
भर्ती जारी
Research Site, Villejuif, 94805, France
भर्ती जारी
Research Site, München, 81675, Germany
भर्ती जारी
Research Site, Ulm, 89081, Germany
भर्ती जारी
Research Site, Würzburg, 97080, Germany
भर्ती जारी
Research Site, Bologna, 40138, Italy
भर्ती जारी
Research Site, Milan, 20133, Italy
भर्ती जारी
Research Site, Chūōku, 104-0045, Japan
भर्ती जारी
Research Site, Kashiwa, 277-8577, Japan
भर्ती जारी
Research Site, Barcelona, 08035, Spain
भर्ती जारी
Research Site, L'Hospitalet de Llobregat, 08908, Spain
भर्ती जारी
Research Site, Madrid, 28040, Spain
भर्ती जारी