Lymphoma, Non-HodgkinPhase 1NCT05557903
Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL
A Phase 1 study testing Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in people with Lymphoma, Non-Hodgkin and Lymphoma, T-Cell, run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
- What is being tested?
- Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 30 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Patients with indications for treatment according to iwCLL2018 criteria and determined by the investigator;
- Age from 18 to 70 (including boundary value), no gender limitation;
- ECOG physical condition score 0 ~ 2;
- 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);
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- 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);
- 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;
- Life expectancy > 3 months;
- 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.
- 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
- Non-hodgkin's lymphoma was confirmed by histopathology according to world Health Organization (WHO) classification of disease, and did not respond to standard treatment;
- ECOG physical condition score 0~2;
- Age from 18 to 70 (including boundary value), no gender limitation;
- Life expectancy > 3 months;
- At least one measurable lesion with a maximum diameter ≥1.5cm is present;
- 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;
- Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the study, and signed written informed consent.
Who cannot join
- For Patients With Relapsed And Refractory CLL/SLL/PLL And Initial Treated T-PLL
- Central nervous system (CNS) or meningeal involvement or history of such involvement before enrollment;
- 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);
- 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;
- Autoimmune cytopenia with clinical manifestations;
- Have a history of active, known autoimmune deficiency, or other acquired, congenital immune deficiency diseases, or a history of organ transplantation;
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- 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;
- 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%;
- Had active systemic infections (bacterial, fungal, viral, etc.) within 2 weeks prior to enrollment, including infections being treated with oral or intravenous antibiotics;
- 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;
- Patients with or clinically suspected Richter's syndrome at the time of screening;
- 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;
- 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;
- Received any live virus vaccine or attenuated live vaccine within 3 months prior to enrollment;
- 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;
- 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;
- Those who have a history of drug abuse or drug abuse after inquiry;
- Pregnant or lactating women;
- 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
- Highly aggressive lymphoma of indolent lymphoma transformation;
- 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;
- 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);
- 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%;
- Lymphoma patients with central nervous system (CNS) invasion before enrollment;
- Known history of prior drug allergy; Or is known to be allergic to protein preparations, biological agents, or any component of the test drug;
- 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;
- Had received autologous or allogeneic hematopoietic stem cell transplantation before enrollment;
- 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;
- 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;
- Participants in other clinical trials within 4 weeks prior to enrollment;
- Received any live virus vaccine or attenuated live vaccine within 3 months prior to enrollment;
- Autoimmune cytopenia with clinical manifestations;
- A history of drug abuse or drug abuse upon inquiry;
- Pregnant or lactating women;
- The investigator considered that the patient had other conditions that might affect compliance or ineligibility for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Najing, Jiangsu, 210011
xiaoge yu, 025-68306360, jsphkj@163.com
About this study
Official title: Recombinant Humanized Anti-CD52 Monoclonal Antibody in the Treatment of Relapsed and Refractory NHL and Initially Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy
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
Read the 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
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
- Being tested
- Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection
- Keywords
- anti-CD52 monoclonal antibody, relapsed and refractory
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Anti-CD52 Monoclonal Antibody InjectionBiological
Also called Anti-CD52 Monoclonal Antibody
Single dosing: DLT observation for 7 days after administration; Multiple dosing: 3times/weeks,12 times, 28 days of DLT observation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group of anti-CD52 monoclonal antibody | Experimental | safety and tolerability, pharmacokinetic characteristics and preliminary efficacy 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 of recombinant humanized anti-cd52 monoclonal antibody injection Receives: Biological: Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Adverse events that occurred during the entire study period were evaluated and graded according to NCI-CTCAE v5.0, and dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) were observed.
Safety evaluation indexes include vital signs, physical examination, 12-lead electrocardiogram, echocardiography, clinical laboratory examination indexes (blood routine, blood biochemistry, urine routine, coagulation function, etc.), changes of ECOG physical fitness score, adverse events and serious adverse event, etc.
Measured: 6 weeks
Secondary outcomes (15)
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Area under the plasma concentration versus time curve(AUC 0-∞)
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Area under the plasma concentration versus time curve(AUC 0-t）
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Peak Plasma Time（Tmax）
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Peak Plasma Concentration（Cmax）
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Plasma clearance（CL）
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Half-life of the drug（t1/2）
Measured: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Steady State Maximum Concentration(Cmax,ss)
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Steady State Minimal Concentration(Cmin,ss)
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Steady State Peak Plasma Time(Tmax.ss)
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Half-life of the drug（t1/2）
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Steady State Area under the plasma concentration versus time curve(AUC 0-t),ss
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
fluctuation degree
Measured: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
fluctuation coefficient
Measured: 11 weeks
Efficacy evaluation of anti-CD52 monoclone antibody
ORR (including CR and PR), disease control rate (DCR), remission duration (DOR) and progression-free survival (PFS) in objective remission rate
Measured: 16 weeks
Immunogenicity evaluation of anti-CD52 monoclone antibody
drug-resistant antibody (ADA) and neutralizing antibody (NAb)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start20 Dec 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jianyong Li, Principal investigator, Jiangsu Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557903
- Sponsor's protocol ID
- RD04-CD52-V01
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Humanized Anti-CD52 Monoclonal Antibody in the Treatment of Relapsed and Refractory NHL and Initially Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT05557903
- Acronym / sponsor ID
- RD04-CD52-V01
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
- Keywords
- anti-CD52 monoclonal antibody, relapsed and refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group of anti-CD52 monoclonal antibody | Experimental | Biological: Recombinant Humanized Anti-CD52 Monoclonal Antibody Injectionsafety and tolerability, pharmacokinetic characteristics and preliminary efficacy 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 of recombinant humanized anti-cd52 monoclonal antibody injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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;
- Patients with indications for treatment according to iwCLL2018 criteria and determined by the investigator;
- Age from 18 to 70 (including boundary value), no gender limitation;
- ECOG physical condition score 0 ~ 2;
Key exclusion criteria (36 listed)
- For Patients With Relapsed And Refractory CLL/SLL/PLL And Initial Treated T-PLL
- For Other Relapsed And Refractory Non-Hodgkin's Lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Humanized Anti-CD52 Monoclonal Antibody InjectionAlso: Anti-CD52 Monoclonal AntibodySingle dosing: DLT observation for 7 days after administration; Multiple dosing: 3times/weeks,12 times, 28 days of DLT observation | Biological | Treatment Group of anti-CD52 monoclonal antibody |
Primary outcome
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Time frame: 6 weeks
Adverse events that occurred during the entire study period were evaluated and graded according to NCI-CTCAE v5.0, and dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) were observed. Safety evaluation indexes include vital signs, physical examination, 12-lead electrocardiogram, echocardiography, clinical laboratory examination indexes (blood routine, blood biochemistry, urine routine, coagulation function, etc.), changes of ECOG physical fitness score, adverse events and serious adverse event, etc.
15 secondary outcomes
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（single administration）
Time frame: 1 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Pharmacokinetic (PK) evaluation of anti-CD52 monoclone antibody（Multiple administration）
Time frame: 11 weeks
Efficacy evaluation of anti-CD52 monoclone antibody
Time frame: 16 weeks
Immunogenicity evaluation of anti-CD52 monoclone antibody
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianyong Li principal investigator
Jiangsu Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in people with Lymphoma, Non-Hodgkin and Lymphoma, T-Cell, run by Lanzhou Institute of Biological Products Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yu xiaoge (025-68306360, jsphkj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.