Trial Title:
Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL
NCT ID:
NCT05557903
Condition:
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Antineoplastic Agents, Immunological
Alemtuzumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Conditions: Keywords:
anti-CD52 monoclonal antibody
relapsed and refractory
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection
Description:
Single dosing: DLT observation for 7 days after administration; Multiple dosing:
3times/weeks,12 times, 28 days of DLT observation
Arm group label:
Treatment Group of anti-CD52 monoclonal antibody
Other name:
Anti-CD52 Monoclonal Antibody
Summary:
Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of
recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL
Detailed description:
Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in the Treatment of
Relapsed and Refractory NHL (Including CLL/SLL, PLL, PTCL, Diffuse Large B-cell Lymphoma,
Follicular Cell Lymphoma, Mantle Cell Lymphoma, and Marginal Zone Lymphoma) and Initially
Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic
Characteristics and Preliminary Efficacy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
For Patients With Relapsed And Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic
Lymphoma/Lymphoblastic Leukemia (CLL/SLL/PLL) And Initial Treated t-Lymphoblastic
Leukemia ( InitialTreated T-PLL)
-Patients with CLL/SLL or PLL were confirmed by histopathological or flow immunotyping;
1. Patients with indications for treatment according to iwCLL2018 criteria and
determined by the investigator;
2. Age from 18 to 70 (including boundary value), no gender limitation;
3. ECOG physical condition score 0 ~ 2;
4. Patients have measurable lesions (lymphadenopathy (maximum baseline diameter ≥1.5
cm), or hepatomegaly/splenomegaly due to CLL or PLL or peripheral tumor lymphocytes
>5×10E9/L);
5. CLL/SLL patients are intolerant or resistant to previous BTK inhibitor treatment; Or
newly treated patients with T-PLL; Or relapse-resistant PLL (relapse-resistant PLL
is defined as disease progression following recent remission of treatment.
Treatment-resistant disease was defined as failure to achieve ≥PR from the most
recent treatment or disease progression within 6 months of the last treatment);
6. Laboratory test results must meet the following requirements (no blood components,
short-acting cell growth factor and other drugs are allowed within 7 days prior to
laboratory test; Long-acting growth factor is not allowed within the first 14 days),
and laboratory test results within 7 days before screening;
- Bone marrow function: Neutrophils ≥1×10E9/L, platelets ≥50×10E9/L, and
hemoglobin ≥75g/L were observed without growth factor support treatment.
- Liver function: AST and ALT ≤2×ULN (no liver invasion); Alanine
aminotransferase or/and aspartate aminotransferase ≤5×ULN (liver aggressor).
Total bilirubin ≤2×ULN;
- Renal function: serum creatinine ≤2×ULN and creatinine clearance rate >
50mL/min;
- Blood coagulation function: international standardized ratio (INR) ≤1.5×ULN and
activated partial thrombin time (APTT) ≤1.5×ULN;
7. Life expectancy > 3 months;
8. Fertile men and women of reproductive age are willing to take effective
contraceptive measures from the signing of informed consent to 6 months after the
last administration of the experimental drug; Women of childbearing age must have a
negative blood pregnancy test no later than 7 days before the first trial drug is
administered.
9. Agreed to follow the experimental treatment plan and visit plan, voluntarily
enrolled in the study, and signed written informed consent.
For Other Relapsed And Refractory Non-Hodgkin's Lymphoma
1. Non-hodgkin's lymphoma was confirmed by histopathology according to world Health
Organization (WHO) classification of disease, and did not respond to standard
treatment;
2. ECOG physical condition score 0~2;
3. Age from 18 to 70 (including boundary value), no gender limitation;
4. Life expectancy > 3 months;
5. At least one measurable lesion with a maximum diameter ≥1.5cm is present;
6. Laboratory test results must meet the following requirements (no blood components,
short acting cell growth factor, albumin and other drugs are allowed to be given
within 7 days before obtaining laboratory test; Long acting growth factor is not
allowed in the first 14 days) :
- Bone marrow function: Neutrophils ≥1×10E9/L, platelets ≥50×10E9/L, and
hemoglobin ≥75g/L were observed without growth factor support treatment.
- Liver function: AST and ALT ≤2×ULN (no liver invasion); Alanine
aminotransferase or/and aspartate aminotransferase ≤5×ULN (liver aggressor).
Total bilirubin ≤2×ULN;
- Renal function: serum creatinine ≤2×ULN and creatinine clearance rate
>50mL/min;
- Blood coagulation function: international standardized ratio (INR) ≤1.5×ULN and
activated partial thrombin time (APTT) ≤1.5×ULN;
7. Agreed to follow the experimental treatment plan and visit plan, voluntarily
enrolled in the study, and signed written informed consent.
Exclusion Criteria:
- For Patients With Relapsed And Refractory CLL/SLL/PLL And Initial Treated T-PLL
1. Central nervous system (CNS) or meningeal involvement or history of such
involvement before enrollment;
2. Received systemic steroid hormone (dose equivalent to prednisone ≥10mg/ day)
and antitumor therapy within 7 days prior to initial administration of the
study drug, chemotherapy, targeted therapy, radiotherapy or antibody therapy
within 4 weeks or 5 half-lives, whichever is older; Failure to recover from AE
associated with prior systemic antitumor therapy to nCI General Adverse Event
Term version 5.0 (CT CAE Version 5.0) grade ≤1 (except hair loss);
3. Those who had undergone major surgery, severe trauma or were expected to
undergo major surgery during the study period within 4 weeks prior to the first
administration of the study drug and were judged by the investigator to be
unsuitable for inclusion;
4. Autoimmune cytopenia with clinical manifestations;
5. Have a history of active, known autoimmune deficiency, or other acquired,
congenital immune deficiency diseases, or a history of organ transplantation;
6. There was a history of other active malignant tumors within 2 years prior to
the entry of the study, except for the following cases :(1) effectively
controlled cervical cancer in situ; (2) effectively controlled local basal cell
carcinoma of skin; (3) Other previous malignant tumors that have been
clinically cured and have no clinical signs for ≥5 years;
7. Currently has clinical significance of cardiovascular disease, activity, such
as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart
failure, according to the New York heart association functional class determine
any 3 or 4 heart disease, or a period of 6 months before screening history of
myocardial infarction, or heart left ventricular ejection fraction < 50%;
8. Had active systemic infections (bacterial, fungal, viral, etc.) within 2 weeks
prior to enrollment, including infections being treated with oral or
intravenous antibiotics;
9. Known patients with acute or chronic active hepatitis b (HBsAg positive and HBV
DNA viral load ≥200IU/mL or ≥10E3 copy number /mL, other abnormal results will
be determined by the investigator whether to add quantitative HBV DNA test or
exclude); Acute or active hepatitis C (HCV antibody positive); And other
acquired, congenital immunodeficiency diseases, including but not limited to
HIV-infected persons; Or treponema pallidum antibody positive; Or CMV-DNA
positive;
10. Patients with or clinically suspected Richter's syndrome at the time of
screening;
11. Patients who received or received radiation therapy within the first 4 weeks of
enrollment (except for treated bone marrow volume less than 10% and patients
with evaluable lesions beyond the radiation report). Prior radioimmunotherapy
within 3 months prior to initiation of the study drug;
12. Are currently participating in an interventional clinical trial treatment, or
have been treated with another clinical trial drug or device within 4 weeks
prior to initial administration;
13. Received any live virus vaccine or attenuated live vaccine within 3 months
prior to enrollment;
14. Prior allogeneic stem cell transplantation or autologous hematopoietic stem
cell transplantation or any active graft-versus-host disease basis or
immunosuppressant use within 21 days prior to initiation of investigational
therapy;
15. Known history of allergic diseases or severe allergies; Or is known to be
allergic to protein preparations, biological agents, or any component of the
test drug;
16. Those who have a history of drug abuse or drug abuse after inquiry;
17. Pregnant or lactating women;
18. The investigator considered that the patient had other conditions that might
affect compliance or ineligibility for the study.
- For Other Relapsed And Refractory Non-Hodgkin's Lymphoma
1. Highly aggressive lymphoma of indolent lymphoma transformation;
2. Known patients with acute or chronic active hepatitis b (HBsAg positive and HBV
DNA viral load ≥200IU/mL or ≥10E3 copy number /mL, other abnormal results will
be determined by the investigator whether to add quantitative HBV DNA test or
exclude); Acute or active hepatitis C (HCV antibody positive); And other
acquired, congenital immunodeficiency diseases, including but not limited to
hiv-infected persons; Or treponema pallidum antibody positive; Or cmV-DNA
positive;
3. Received any anti-tumor therapy (including radiotherapy, chemotherapy, hormone
therapy [dose equivalent to prednisone ≥10mg/ day], surgery or targeted
therapy, immunotherapy, etc.) within 4 weeks or 5 half-life periods (whichever
is longer) prior to the start of the study drug; Recovery from AE associated
with prior systemic antitumor therapy to NCI General Adverse Event Term version
5.0 (CT CAE Version 5.0) grade ≤1 (except hair loss);
4. Clinically significant heart disease, including unstable angina, acute
myocardial infarction 6 months prior to randomization, congestive heart failure
(NYHA) heart function grade III or IV; Or left ventricular ejection fraction <
50%;
5. Lymphoma patients with central nervous system (CNS) invasion before enrollment;
6. Known history of prior drug allergy; Or is known to be allergic to protein
preparations, biological agents, or any component of the test drug;
7. Those who had undergone major surgery or severe trauma within 4 weeks prior to
treatment and were judged by the investigator to be unfit for inclusion;
8. Had received autologous or allogeneic hematopoietic stem cell transplantation
before enrollment;
9. There was a history of other active malignant tumors within 2 years before
entering the study, except for the following cases :(1) effectively controlled
cervical cancer in situ; (2) effectively controlled local basal cell carcinoma
of skin; (3) Other malignant tumors that have been clinically cured and have no
clinical signs for ≥5 years;
10. Had an active systemic infection (bacterial, fungal, viral, etc.) within 2
weeks prior to enrollment, including an infection being treated with oral or
intravenous antibiotics;
11. Participants in other clinical trials within 4 weeks prior to enrollment;
12. Received any live virus vaccine or attenuated live vaccine within 3 months
prior to enrollment;
13. Autoimmune cytopenia with clinical manifestations;
14. A history of drug abuse or drug abuse upon inquiry;
15. Pregnant or lactating women;
16. The investigator considered that the patient had other conditions that might
affect compliance or ineligibility for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Najing
Zip:
210011
Country:
China
Status:
Recruiting
Contact:
Last name:
xiaoge yu
Phone:
025-68306360
Email:
jsphkj@163.com
Start date:
December 20, 2021
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Lanzhou Institute of Biological Products Co., Ltd
Agency class:
Industry
Source:
Lanzhou Institute of Biological Products Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557903
