Recurrent Diffuse Large B-Cell LymphomaPhase 1NCT06047197
Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma
A Phase 1 study testing RC19D2 cell injection in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by Beijing Yongtai Ruike Biotechnology Company Ltd at 1 site in China.
Trial summary
This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
- What is being tested?
- RC19D2 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2023to 5 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form;
- Age ≥ 18 years old at the time of screening, regardless of gender;
- Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and/or cytology, but have failed standard treatment in the early stage, and currently lack effective treatment methods for recurrent or refractory CD19 positive.
- The regulations for the past treatment status of research participants are as follows (meeting at least one of them): 1.At least after sufficient second-line treatment (CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs), recurrence, no remission, or progression; In the first two lines of treatment, if the optimal therapeutic effect is SD, then the line of treatment must have completed 2 cycles;2.Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation;
- According to the 2023 NCCN Lymphoma Treatment Guidelines and the 4th edition of the WHO Lymphatic Tissue Tumor Classification in 2016, the following types were included in this trial:Diffuse large B-cell lymphoma (DLBCL) non-specific (DLBCL-NOS)；Transforming follicular lymphoma (tFL)；High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement；High grade B-cell lymphoma, non-specific (HGBL-NOS)；Primary mediastinal large B-cell lymphoma (PMBL)；Grade 3b follicular lymphoma (FL3b);
- Expected survival time ≥ 12 weeks;
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- There are measurable target lesions in imaging: the length and diameter of lesions in lymph nodes ≥ 15mm, or extranodal lesions>10mm (according to Lugano2014 standard); Lesions that have received radiotherapy in the past are considered measurable only when there is clear progress after completing radiotherapy;
- During screening, laboratory inspections must meet the following requirements:Neutrophil count ≥ 1.0 × 10^9/L;Lymphocyte count ≥ 0.3 × 10^9/L; Hemoglobin ≥ 70 g/L;Platelets ≥ 50 × 10^9/L;Total serum bilirubin ≤ 2.0 × Upper limit of normal value (ULN);Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;Creatinine<1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL/min (creatinine clearance rate Cockcroft Fault method: male creatinine clearance rate=[(140 age) × Weight (kg)]/[0.818 × Creatinine（ μ Mol/L)]; Female creatinine clearance rate=[(140 age) × Body weight (kg) × 0.85]/[0.818 × Creatinine（ μ Mol/L)].
- The lung function is good, and the blood oxygen saturation of the fingertip pulse under non oxygen inhalation is ≥ 92%;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0 or 1;
- Head MRI shows no central nervous system lymphoma;
- Cardiac ultrasound shows left ventricular ejection fraction ≥ 50%; No clinically significant abnormal electrocardiogram findings; No clinically significant pericardial or pleural effusion;
- Adequate venous access (for single collection) and no other contraindications for blood cell separation;
- The screening period blood pregnancy test for female participants of childbearing age must be negative
Who cannot join
- Individuals with a history of allergies to any component in cellular products;
- Individuals with a history of allogeneic hematopoietic stem cell transplantation;
- Individuals with a history of organ transplantation;
- hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the HBV-DNA quantity is higher than the upper limit of normal value; Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values; Positive for human immunodeficiency virus antibody (HIV-Ab); Positive anti Treponema pallidum antibody (TP Ab); Cytomegalovirus DNA quantification is higher than the upper limit of normal values; EB virus DNA quantification is higher than the upper limit of normal values;
- CNS diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, paralysis, aphasia, cerebral vascular ischemia/bleeding, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc;
- Patients with active primary or secondary central nervous system (CNS) lymphoma (patients with CNS disease symptoms must undergo lumbar puncture examination to rule out CNS lymphoma).
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- Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19;
- Having severe genetic or autoimmune diseases (such as systemic lupus erythematosus);
- Screening for thromboembolic events within the first 6 months (such as myocardial infarction, pulmonary infarction, deep vein thrombosis, and other systemic thrombotic diseases);
- Screening for malignant tumors other than those indicated in this study within the first 5 years, except for tumors in situ (such as cervical cancer, bladder, breast cancer) or non melanoma skin cancer;
- Active or uncontrollable infections that require systemic treatment;
- Within 9 months prior to PBMC collection, received treatment with Bendamustine、Alenzumab, Fludarabine,and Cladribine;;
- Within 4 weeks prior to PBMC collection, patients received naloxamine, calcineurin inhibitors, chemotherapy drugs (methotrexate, cyclophosphamide, ifosfamide, benzoate nitrogen mustard or mefalam,), mycophenolate, thalidomide, immunosuppressive antibodies such as anti TNF, anti IL6, or anti IL6R therapy, tumor radiotherapy, or drugs that can bind to FKBP 12 protein (such as rapamycin, tacrolimus, everolimus, etc.);
- Long acting cell growth factors (such as polyethylene glycol recombinant human granulocyte stimulating factor PEG-rhG-CSF) were used within 3 weeks prior to PBMC collection;
- Received granulocyte macrophage colony stimulating factor (GM-CSF) treatment within 2 weeks prior to PBMC collection;
- Individuals who have received short-term cell growth factors (such as recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin, etc.), hematopoiesis agonists/stimulators (such as haitrapopa ethanolamine tablets), CD20 monoclonal antibodies, and corticosteroids within 7 days prior to PBMC collection (excluding those who have received inhaled, local steroid therapy, and physiological replacement therapy for adrenal insufficiency);
- Received platelet transfusion within 7 days before the screening period;
- Pregnant or lactating women, or men or women with fertility potential, refuse to use contraception during the trial period and at the end of the trial (2 years after RC19D2 cell reinfusion);
- Patients who have participated in other drug clinical trials within 4 weeks prior to PBMC collection (new drug clinical trials, registered studies, clinical studies initiated by researchers, etc.);
- The researcher believes that this clinical trial is not suitable (such as poor compliance, drug abuse, etc.);
- Those who have received live or attenuated vaccines within 3 months prior to PBMC collection, or are expected to need to receive such vaccines during this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Lugui QIU, M.D., 13821266636, qiulg@ihcams.ac.cn
About this study
Official title: Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma
This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma
Read the detailed description
This trial is a Phase I clinical trial, which is divided into two trial stages. The first stage is a dose-increasing trial stage The second stage is the dose extension experiment stage.
The main endpoint is to evaluate its tolerance and safety. The first dose group used rapid titration method for dose increase, and the subsequent dose groups used the classic 3+3 experimental design for dose increase. A total of 4 dose groups are planned to be set up. The second to fourth dose groups will include 3-6 participants in each group
- Being tested
- RC19D2 cell injection
- Keywords
- CD19, CAR-T, RC19D2, DLBCL
- 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.
RC19D2 cell injectionBiological
The functional component of RC19D2 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.
| Study group | Role | What they receive |
|---|---|---|
| First dose group | Experimental | The initial dose is (0.5 ± 0.1) × 10^6/kg, with 1 participant enrolled Receives: Biological: RC19D2 cell injection |
| Second dose group | Experimental | The second dose is (1.0 ± 0.2) × 10^6/kg, with 3-6 study participants enrolled Receives: Biological: RC19D2 cell injection |
| Third dose group | Experimental | The third dose is (2.5± 0.5) × 10^6/kg, with 3-6 study participants enrolled Receives: Biological: RC19D2 cell injection |
| Fourth dose group | Experimental | The fourth dose is (5± 1) × 10^6/kg, with 3-6 study participants enrolled Receives: Biological: RC19D2 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Determine the maximum tolerable dose(MTD) based on the 28 day dose limit toxicity occurrence of all participants.
Measured: 28 days
AE Safety
Number of participants with Adverse event (AESI, ADR, SAE, etc.), with abnormal laboratory test results, abnormal vital signs, abnormal physical examination findings and abnormal 12 lead electrocardiogram readings
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Sep 2023
- Primary completion5 Sep 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Diffuse Large B-Cell LymphomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Yongtai Ruike Biotechnology Company Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lugui Qiu, MD, Principal investigator, blood diseases hospital，chinese academy of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047197
- Sponsor's protocol ID
- RC19D2-r/r DLBCL-01
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06047197
- Acronym / sponsor ID
- RC19D2-r/r DLBCL-01
- Keywords
- CD19, CAR-T, RC19D2, DLBCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Beijing Yongtai Ruike Biotechnology Company LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (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 trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma
Detailed description
This trial is a Phase I clinical trial, which is divided into two trial stages. The first stage is a dose-increasing trial stage The second stage is the dose extension experiment stage.
The main endpoint is to evaluate its tolerance and safety. The first dose group used rapid titration method for dose increase, and the subsequent dose groups used the classic 3+3 experimental design for dose increase. A total of 4 dose groups are planned to be set up. The second to fourth dose groups will include 3-6 participants in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First dose group | Experimental | Biological: RC19D2 cell injectionThe initial dose is (0.5 ± 0.1) × 10^6/kg, with 1 participant enrolled |
| Second dose group | Experimental | Biological: RC19D2 cell injectionThe second dose is (1.0 ± 0.2) × 10^6/kg, with 3-6 study participants enrolled |
| Third dose group | Experimental | Biological: RC19D2 cell injectionThe third dose is (2.5± 0.5) × 10^6/kg, with 3-6 study participants enrolled |
| Fourth dose group | Experimental | Biological: RC19D2 cell injectionThe fourth dose is (5± 1) × 10^6/kg, with 3-6 study participants enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Understand and voluntarily sign the informed consent form;
- Age ≥ 18 years old at the time of screening, regardless of gender;
- Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and/or cytology, but have failed standard treatment in the early stage, and currently lack effective treatment methods for recurrent or refractory CD19 positive.
- The regulations for the past treatment status of research participants are as follows (meeting at least one of them): 1.At least after sufficient second-line treatment (CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs), recurrence, no remission, or progression; In the first two lines of treatment, if the optimal therapeutic effect is SD, then the line of treatment must have completed 2 cycles;2.Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation;
- According to the 2023 NCCN Lymphoma Treatment Guidelines and the 4th edition of the WHO Lymphatic Tissue Tumor Classification in 2016, the following types were included in this trial:Diffuse large B-cell lymphoma (DLBCL) non-specific (DLBCL-NOS)；Transforming follicular lymphoma (tFL)；High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement；High grade B-cell lymphoma, non-specific (HGBL-NOS)；Primary mediastinal large B-cell lymphoma (PMBL)；Grade 3b follicular lymphoma (FL3b);
Key exclusion criteria (21 listed)
- Individuals with a history of allergies to any component in cellular products;
- Individuals with a history of allogeneic hematopoietic stem cell transplantation;
- Individuals with a history of organ transplantation;
- hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the HBV-DNA quantity is higher than the upper limit of normal value; Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values; Positive for human immunodeficiency virus antibody (HIV-Ab); Positive anti Treponema pallidum antibody (TP Ab); Cytomegalovirus DNA quantification is higher than the upper limit of normal values; EB virus DNA quantification is higher than the upper limit of normal values;
- CNS diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, paralysis, aphasia, cerebral vascular ischemia/bleeding, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc;
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 |
|---|---|---|
| RC19D2 cell injectionThe functional component of RC19D2 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors. | Biological | First dose group, Fourth dose group, Second dose group, Third dose group |
Primary outcome
MTD
Time frame: 28 days
Determine the maximum tolerable dose(MTD) based on the 28 day dose limit toxicity occurrence of all participants.
AE Safety
Time frame: 2 years
Number of participants with Adverse event (AESI, ADR, SAE, etc.), with abnormal laboratory test results, abnormal vital signs, abnormal physical examination findings and abnormal 12 lead electrocardiogram readings
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
lugui Qiu, MD principal investigator
blood diseases hospital，chinese academy of medical sciences
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 RC19D2 cell injection in people with Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by Beijing Yongtai Ruike Biotechnology Company 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 14 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: looking for participants now, as of the sponsor's last update on 27 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lugui Qiu, MD (13821266636 ext. +86, qiulg@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 28 days). The study lists 2 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 27 Aug 2024.