Diffuse Large B Cell LymphomaNCT05269914
Safety, Efficacy and Pharmacokinetics of XKDCT023 in DLBCL
A study testing Autologous anti-CD19 CAR-T cell injection in people with Diffuse Large B Cell Lymphoma, run by The Affiliated Hospital of Qingdao University.
Trial summary
This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 days
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Autologous anti-CD19 CAR-T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to 30 Jun 2023
- Phase
- Interventional
- 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 75 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All subjects or legal guardians must sign the informed consent approved by the ethics committee in writing before starting any screening procedure.
- Adult patients aged 18 and over with recurrent or refractory DLBCL.
- Bone marrow negative or bone marrow lymphoma cells in screening stage determined by CT scan < 30%.
- The subject had been adequately treated before.
- According to the revised IWG malignant lymphatic efficacy evaluation criteria (2007 Edition), there was at least one measurable lesion in the baseline period.
- Estimated survival ≥ 12 weeks.
Show all 13Show fewer
- The baseline ECoG score was 0 or 1.
- Adequate organ function.
- Hemodynamics determined by echocardiography or multichannel radionuclide angiography (MUGA) were stable and left ventricular ejection fraction (LVEF) ≥ 45%.
- Sufficient bone marrow reserve without blood transfusion.
- There must be non mobilized apheresis or peripheral blood collected cells for car-t cell production.
- According to the judgment of the researcher, the patient has fully recovered from the toxicity of previous anti-tumor treatment and is suitable for pretreatment chemotherapy and car-t cell treatment.
- Women of childbearing age and all male subjects must agree to use efficient contraceptive methods until at least 12 months after xkdct023 infusion, and until two consecutive PCR tests show that car-t cells are no longer present in the body.
Who cannot join
- Patients who have previously received any anti-CD19 / anti-CD3 treatment, or any other anti-CD19 treatment;
- Patients previously treated with any gene therapy product, including car-t treatment;
- Patients with detectable cerebrospinal fluid malignant cells or brain metastasis, or patients with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma;
- Patients with testicular invasion, including patients with orchiectomy;
- Patients with current or history of central nervous system diseases, such as epilepsy, cerebrovascular ischemia / hemorrhage, dementia, cerebellar diseases or any autoimmune diseases involving the central nervous system;
- Patients who had previously received allogeneic hematopoietic stem cell transplantation (HSCT);
Show all 21Show fewer
- Patients who are suitable and willing to receive autologous hematopoietic stem cell transplantation (ASCT);
- The feasibility evaluation screening stage showed that the lymphocyte transfection efficiency of patients was less than 5%, or patients whose T cell culture could not be expanded (< 5 times).
- Patients who received chemotherapy other than lymphocyte clearance chemotherapy within 2 weeks before xkdct023 infusion;
- Patients who had received other study drugs within 30 days before screening;
- Patients who received radiotherapy within 2 weeks before infusion;
- Active hepatitis B (defined as hepatitis B virus DNA detection value > 1000 copies/ml) or hepatitis C virus (HCV RNA positive) patients.
- HIV positive or Treponema pallidum positive patients;
- Patients with acute life-threatening bacterial, viral or fungal infections that have not been controlled (e.g. positive blood culture ≤ 72 hours before infusion);
- Patients with unstable angina pectoris and / or myocardial infarction within 6 months before screening;
- Patients with previous or concurrent malignancies, with the following exceptions: well treated basal cell or squamous cell carcinoma (sufficient wound healing is required before enrollment in the study); Cervical cancer or breast cancer in situ cancer, after curable treatment, had no recurrence at least 3 years before the study. The primary malignant tumor has been completely removed and completely relieved for ≥ 5 years.
- Pregnant or lactating female patients (women of childbearing age are verified as positive results by serum or urine pregnancy test during the screening period);
- There are arrhythmia patients without medical management control;
- Patients who received oral anticoagulant therapy within 1 week before car-t cell infusion;
- Patients who had previously received any adoptive T cell therapy;
- active neuroautoimmune or inflammatory disorders (e.g. Guillian Barre syndrome, amyotrophic lateral sclerosis).
About this study
Official title: Safety, Efficacy and Pharmacokinetics of XKDCT023 in Adult Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma
This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. The first dose group has one patient. If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be enrolled according to the "3 + 3" method; The follow-up dose group is conducted according to the traditional "3 + 3" design, that is, three subjects are first enrolled in a dose group. If there is no dose limiting toxicity (DLT) in the three patients in the dose group, it can be increased to the next higher dose after completing the DLT observation period; If DLT occurs in 1 of the 3 patients in the dose group, it is necessary to continue to enroll 3 patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to 1 of the last 6 confirmed patients will be defined as MTD. The safety of car-t treatment was evaluated by observing the adverse events after cell therapy; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion, the number and activity of car-t cells were detected, and the pharmacokinetics (PK) of car-t cells was evaluated.
Read the detailed description
This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There were three dose groups in the study, and one patient in the first dose group, If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be included in the group according to the "3 + 3" method; the follow-up dose group is designed according to the traditional "3 + 3" design, that is, three subjects will be included in a dose group first, if there is no dose limiting toxicity in the three patients in the dose group (DLT), after completing the DLT observation period, it can be increased to the next higher dose; if one of the three patients in the dose group has DLT, it is necessary to continue to join the group of three patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to one of the six patients finally confirmed will be defined as MTD. By observing the adverse events after cell therapy, the patients will be evaluated Evaluate the safety of car-t treatment; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion to detect the number and activity of car-t cells, Evaluate the pharmacokinetics (PK) of car-t cells. During the study, the blood samples used for the production of car-t cells will be transported to Shenzhen xiankangda Life Sciences Co., Ltd. (sponsor). After the production of car-t cells is completed, the car-t cells will be sent to the research unit so that the researchers can infuse them to the corresponding subjects.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Autologous anti-CD19 CAR-T cell injection
- Keywords
- Diffuse large B-cell lymphoma, Autologous anti-CD19 CAR-T cells
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous anti-CD19 CAR-T cell injectionOther
According to preclinical research, existing preliminary clinical data and similar approved therapeutic products (kte-c19 of Kate company, the trade name is yescarta ®） According to the clinical trial results, three doses (the number of cells per unit body weight) were selected as the therapeutic dose of this study. Among the patients who increased the dose according to the "3 + 3" design, the number of target cells in each dose group was: (1) the first dose group was 1.00 × 106 Car + T cells / kg, 20% dose error is allowed. (2) the second dose group is 3.00 × 106 Car + T cells / kg, 20% dose error is allowed. (3) the third dose group is 9.00 × 106 Car + T cells / kg, 20% dose error is allowed.
| Study group | Role | What they receive |
|---|---|---|
| Autologous anti-CD19 CAR-T cell injection | Experimental | with 1.00×106 CAR+T cells/kg, 3.00×106 CAR+T cells /kg and 9.00×106 CAR+T cells/kg Receives: Other: Autologous anti-CD19 CAR-T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Type, incidence and severity of adverse events
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Maximum tolerated dose
The maximum dose that does not cause death of the subject
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Recommended dose for phase II
Determine the recommended dose for phase II clinical trials
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Secondary outcomes (9)
Peak time,Tmax
Venous blood samples were collected once during the infusion period D1, D2, D4, D6, D8, D10, D12, D14, D16, D18, D21, D24, d27, d30 and follow-up period. The proportion and count of car-t cells in peripheral blood and bone marrow were detected by flow cytometry and RT-PCR, and the PK parameters, PK characteristics and distribution of car-t cells in bone marrow were evaluated. The probe method of fluorescence quantitative PCR was used to monitor the copy number of CAR.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Maximum concentration, Cmax
Venous blood samples were collected once during the infusion period D1, D2, D4, D6, D8, D10, D12, D14, D16, D18, D21, D24, d27, d30 and follow-up period. The proportion and count of car-t cells in peripheral blood and bone marrow were detected by flow cytometry and RT-PCR, and the PK parameters, PK characteristics and distribution of car-t cells in bone marrow were evaluated. The probe method of fluorescence quantitative PCR was used to monitor the copy number of CAR.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Area Under Curve, AUC1-30d
Venous blood samples were collected once during the infusion period D1, D2, D4, D6, D8, D10, D12, D14, D16, D18, D21, D24, d27, d30 and follow-up period. The proportion and count of car-t cells in peripheral blood and bone marrow were detected by flow cytometry and RT-PCR, and the PK parameters, PK characteristics and distribution of car-t cells in bone marrow were evaluated. The probe method of fluorescence quantitative PCR was used to monitor the copy number of CAR.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Pharmacodynamics
The peak value of cytokines within 1 month after car-t cell infusion and the time to return to the baseline state or normal range.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Total remission rate
The total remission rate of each dose group and all patients evaluated at 1 month, 3 months, 6 months, 9 months and 12 months after car-t treatment.M3 was scanned with systemic CT ± head, neck, chest, abdomen and pelvis enhanced CT. For M6, M9 and M12, enhanced CT or MRI of head, neck, chest and abdominal basin was used.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Complete remission rate
The complete remission rate of each dose group and all patients evaluated at 1 month, 3 months, 6 months, 9 months and 12 months after car-t treatment.M3 was scanned with systemic CT ± head, neck, chest, abdomen and pelvis enhanced CT. For M6, M9 and M12, enhanced CT or MRI of head, neck, chest and abdominal basin was used.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Partial remission rate
The partial remission rate of each dose group and all patients evaluated at 1 month, 3 months, 6 months, 9 months and 12 months after car-t treatment.M3 was scanned with systemic CT ± head, neck, chest, abdomen and pelvis enhanced CT. For M6, M9 and M12, enhanced CT or MRI of head, neck, chest and abdominal basin was used.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Distribution of car-t cells in bone marrow
The proportion and count of car-t cells in peripheral blood and bone marrow were detected by flow cytometry and RT-PCR to evaluate the distribution of car-t cells in bone marrow. The probe method of fluorescence quantitative PCR was used to monitor the copy number of CAR.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Survival of car-t cells
Survival of car-t cells in adult patients with recurrent or refractory DLBCL.
Measured: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study startApr 2022 (estimated)
- Primary completion31 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 Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single infusion of autologous anti-CD19 car-t cells
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269914
- Sponsor's protocol ID
- XKDCT023-DLBCL
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2021
- Last updated
- 8 Mar 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Pharmacokinetics of XKDCT023 in Adult Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05269914
- Acronym / sponsor ID
- XKDCT023-DLBCL
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Autologous anti-CD19 CAR-T cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Mar 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.
This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There are three dose groups in the study. The first dose group has one patient. If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be enrolled according to the "3 + 3" method; The follow-up dose group is conducted according to the traditional "3 + 3" design, that is, three subjects are first enrolled in a dose group. If there is no dose limiting toxicity (DLT) in the three patients in the dose group, it can be increased to the next higher dose after completing the DLT observation period; If DLT occurs in 1 of the 3 patients in the dose group, it is necessary to continue to enroll 3 patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to 1 of the last 6 confirmed patients will be defined as MTD. The safety of car-t treatment was evaluated by observing the adverse events after cell therapy; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion, the number and activity of car-t cells were detected, and the pharmacokinetics (PK) of car-t cells was evaluated.
Detailed description
This study is a phase I multicenter, single arm, open, dose increasing, single treatment clinical study. This study plans to recruit a total of about 10-16 adult patients with CD19 positive recurrent or refractory DLBCL for a single autologous car-t cell therapy. There were three dose groups in the study, and one patient in the first dose group, If there is no dose limiting toxicity (DLT), it can be increased to the second dose group, otherwise it will continue to be included in the group according to the "3 + 3" method; the follow-up dose group is designed according to the traditional "3 + 3" design, that is, three subjects will be included in a dose group first, if there is no dose limiting toxicity in the three patients in the dose group (DLT), after completing the DLT observation period, it can be increased to the next higher dose; if one of the three patients in the dose group has DLT, it is necessary to continue to join the group of three patients in the dose group for DLT observation. The highest dose level of DLT in less than or equal to one of the six patients finally confirmed will be defined as MTD. By observing the adverse events after cell therapy, the patients will be evaluated Evaluate the safety of car-t treatment; Evaluate the effectiveness of car-t treatment compared with the results or historical data of the patient's own previous standard treatment regimen. Blood and bone marrow were collected before and 12 months after cell infusion to detect the number and activity of car-t cells, Evaluate the pharmacokinetics (PK) of car-t cells. During the study, the blood samples used for the production of car-t cells will be transported to Shenzhen xiankangda Life Sciences Co., Ltd. (sponsor). After the production of car-t cells is completed, the car-t cells will be sent to the research unit so that the researchers can infuse them to the corresponding subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single infusion of autologous anti-CD19 car-t cells
| Arm | Type | Receives |
|---|---|---|
| Autologous anti-CD19 CAR-T cell injection | Experimental | Other: Autologous anti-CD19 CAR-T cell injectionwith 1.00×106 CAR+T cells/kg, 3.00×106 CAR+T cells /kg and 9.00×106 CAR+T cells/kg |
Who may qualify
- Ages
- 18 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- All subjects or legal guardians must sign the informed consent approved by the ethics committee in writing before starting any screening procedure.
- Adult patients aged 18 and over with recurrent or refractory DLBCL.
- Bone marrow negative or bone marrow lymphoma cells in screening stage determined by CT scan < 30%.
- The subject had been adequately treated before.
- According to the revised IWG malignant lymphatic efficacy evaluation criteria (2007 Edition), there was at least one measurable lesion in the baseline period.
Key exclusion criteria (21 listed)
- Patients who have previously received any anti-CD19 / anti-CD3 treatment, or any other anti-CD19 treatment;
- Patients previously treated with any gene therapy product, including car-t treatment;
- Patients with detectable cerebrospinal fluid malignant cells or brain metastasis, or patients with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma;
- Patients with testicular invasion, including patients with orchiectomy;
- Patients with current or history of central nervous system diseases, such as epilepsy, cerebrovascular ischemia / hemorrhage, dementia, cerebellar diseases or any autoimmune diseases involving the central nervous system;
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 |
|---|---|---|
| Autologous anti-CD19 CAR-T cell injectionAccording to preclinical research, existing preliminary clinical data and similar approved therapeutic products (kte-c19 of Kate company, the trade name is yescarta ®） According to the clinical trial results, three doses (the number of cells per unit body weight) were selected as the therapeutic dose of this study. Among the patients who increased the dose according to the "3 + 3" design, the number of target cells in each dose group was: (1) the first dose group was 1.00 × 106 Car + T cells / kg, 20% dose error is allowed. (2) the second dose group is 3.00 × 106 Car + T cells / kg, 20% dose error is allowed. (3) the third dose group is 9.00 × 106 Car + T cells / kg, 20% dose error is allowed. | Other | Autologous anti-CD19 CAR-T cell injection |
Primary outcome
Adverse event
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Type, incidence and severity of adverse events
Maximum tolerated dose
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
The maximum dose that does not cause death of the subject
Recommended dose for phase II
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Determine the recommended dose for phase II clinical trials
9 secondary outcomes
Peak time,Tmax
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Maximum concentration, Cmax
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Area Under Curve, AUC1-30d
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Pharmacodynamics
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Total remission rate
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Complete remission rate
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Partial remission rate
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Distribution of car-t cells in bone marrow
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Survival of car-t cells
Time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
Related trials for Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous anti-CD19 CAR-T cell injection in people with Diffuse Large B Cell Lymphoma, run by The Affiliated Hospital of Qingdao University.
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 13 inclusion and 21 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: The follow-up visit within 2 months is allowed to have a time window of ± 2 days, and the follow-up visit from the 3rd to 12th months is allowed to have a time window of ± 5 days.). The study lists 3 primary outcomes in all. 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 8 Mar 2022.