B Cell MalignanciesEarly Phase 1NCT06519344
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20/CD30-CAR-T Cell Infusion in Relapsed/Refractory Lymphoma Patients.
A Early Phase 1 study testing anti-CD20/CD30-CAR-T Cells in people with B Cell Malignancies, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
Trial summary
This study is a single-center,open-label,single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after lymphocyte depletion pre-treatment. In this study phase,a traditional "3+3"trial design is employed for dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B Cell Malignancies
- What is being tested?
- anti-CD20/CD30-CAR-T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2024to 30 Jul 2027
- Phase
- Early 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the clinical study; complete understanding by self or legally authorized guardian, informed of the study, and signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.
- Age between 18 and 70 years.
- Patients refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and unsuitable for other treatment options such as second hematopoietic stem cell transplantation. Refractory/relapsed lymphoma is defined as:
- No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):
- Progression of Disease (PD) assessment after first-line treatment
- Best response of Stable Disease (SD) after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD maintenance duration not exceeding 6 months after the last dose.
Show all 39Show fewer
- No response to second-line or subsequent therapies:
- PD as best response to the most recent treatment regimen
- Best response of SD after at least 2 cycles of last-line treatment, with SD maintenance duration not exceeding 6 months after the last dose.
- Refractory post autologous stem cell transplantation (ASCT):
- Disease progression or relapse ≤12 months after ASCT (relapsing subjects must have biopsy-proven relapse)
- If salvage therapy is performed post-ASCT, subjects must have had no response or relapse after the last-line treatment.
- Relapsed or refractory disease after two or more lines of systemic therapy.
- Lymphoma patients with target antigens meeting the following criteria:
- CD20/CD30 double-positive lymphomas
- Relapse after anti-CD19-CAR-T cell therapy, and CD20-positive lymphomas
- Never received anti-CD19-CAR-T cell therapy, CD20-positive lymphomas
- CD30-positive Hodgkin lymphoma.
- Included lymphoma subtypes:
- DLBCL-NOS (Diffuse Large B-Cell Lymphoma, not otherwise specified)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- Transformed follicular lymphoma (TFL), previously treated with follicular lymphoma chemotherapy, subsequently transformed into DLBCL, refractory disease
- Mantle cell lymphoma
- High-grade B-cell lymphoma
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
- Hodgkin lymphoma (HL).
- ECOG performance status ≤2.
- Expected survival of at least 12 weeks.
- Adequate venous access (for single collection), and no other contraindications for blood cell separation.
- Laboratory requirements at screening, with no hematologic evaluation within 7 days of receiving growth factors (long-acting granulocyte colony-stimulating factor (G-CSF/PEG-CSF) requires a 2-week interval):
- Absolute neutrophil count ≥1.0×10^9/L;
- Hemoglobin ≥60 g/L (without red blood cell transfusion within 7 days);
- Platelets ≥50×10^9/L (CLL indication unrestricted);
- Serum total bilirubin ≤1.5× upper limit of normal (ULN); or ≤3× ULN if liver tissue invasion by tumor;
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5× ULN, AST/ALT ≤5× ULN if liver tissue invasion by tumor;
- Creatinine <1.5× ULN and estimated glomerular filtration rate ≥60 mL/minute.
- Left ventricular ejection fraction ≥45%, echocardiogram (ECHO) showing no clinically significant pericardial effusion (excluding minimal or physiological effusions), and no clinically significant findings on electrocardiogram.
- Baseline oxygen saturation >92% without supplemental oxygen.
- Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential).
Who cannot join
- Here is the translation of the exclusion criteria for participants in a clinical study:
- Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless CNS involvement has been effectively treated (i.e., participant is asymptomatic) and there has been a local treatment interval of >4 weeks prior to enrollment.
- Active central nervous system diseases such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.
- History of or concurrent malignancies other than CD19+ malignancies.
- Clinically significant cardiac disease, or arrhythmias not controlled by medication.
- Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous antibiotics; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed.
Show all 26Show fewer
- Hepatitis B (positive hepatitis B surface antigen and hepatitis B DNA >1000 copies/mL) and hepatitis C (positive hepatitis C antibody).
- Presence of any indwelling catheters or drainage tubes (e.g., percutaneous nephrostomy tube, Foley catheter, bile drainage tube, pleural/peritoneal/pericardial catheter); specialized central venous access devices like Port-A-Cath® or Hickman® catheters are allowed.
- Use of the following medications prior to:
- 1) Ibrutinib within 1 day before apheresis. 2) Idelalisib (oral PI3Kδ inhibitor) within 2 days before apheresis. 3) Short-acting targeted therapy (such as tyrosine kinase inhibitors) within 72 hours before apheresis.
- 4) Venetoclax (BCL-2 inhibitor) within 4 days before apheresis. 5) Long-acting growth factors (such as pegfilgrastim) within 14 days before apheresis, or short-acting growth factors or mobilizing agents (such as granulocyte colony-stimulating factor (G-CSF)/filgrastim) within 5 days before apheresis.
- 6) Pharmacologic doses of corticosteroid therapy (>5 mg/day prednisone or equivalent) and other immunosuppressive drugs within 7 days before enrollment.
- 7) Radiotherapy within 14 days before enrollment. 8) Systemic cytotoxic drugs within 14 days before enrollment, including daily or weekly low-dose maintenance chemotherapy (e.g., cyclophosphamide, fludarabine, bendamustine, chlorambucil, methotrexate, vinblastine).
- If bridging therapy is administered post-apheresis, there must be at least a 7-day interval between bridging therapy and CAR-T cell infusion.
- 9) Anti-PD1 or anti-PDL1 therapy within 4 weeks before enrollment. 10) Vaccination within 4 weeks before enrollment. 11) Donor lymphocyte infusion (DLI) within 4 weeks before enrollment. 12) Immunostimulatory or immunosuppressive therapy within 3 months before enrollment (such as interferon-α, interferon-β, IL-2, lenalidomide, efalizumab, alemtuzumab, cyclosporine, or methotrexate).
- Active graft-versus-host disease (GVHD) using the CIBMTR acute GVHD grading system ≥ grade 2 or requiring systemic steroids greater than physiological doses.
- History in the past 2 years of autoimmune diseases causing end-organ damage or requiring systemic immunosuppressive/disease-modifying agents, such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus.
- History in the past 12 months of myocardial infarction, cardiac vascular procedures or stent implantation, unstable angina, or other clinically significant cardiac diseases.
- History of genetic syndromes with bone marrow failure, such as Fanconi anemia, Costello syndrome, Shwachman-Diamond syndrome.
- Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation therapy within 6 months before enrollment. Subjects requiring prophylactic anticoagulation are allowed.
- History of concurrent or prior malignancies (excluding basal cell carcinoma of the skin, in situ carcinoma of the breast/cervix, and other malignancies effectively controlled without treatment within the past five years).
- Use of other investigational medicinal products within 30 days before screening.
- Pregnant or lactating women of childbearing potential. Women who have undergone surgical sterilization or who are at least 2 years postmenopausal are not considered of childbearing potential.
- Participants unwilling to use contraception from agreeing to treatment until completion of lymphocyte depletion chemotherapy or CAR-T cell infusion within 12 months (whichever is longer).
- Any medical activities that could potentially interfere with the safety or efficacy evaluation of the study treatment.
- According to the investigator's judgment, participants who are unlikely to complete all study visits or procedures required by the protocol (including follow-ups), or comply with the requirements of participating in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single-center,open-label,single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after lymphocyte depletion pre-treatment.
In this study phase,a traditional "3+3"trial design is employed for dose escalation.
Read the detailed description
This study is a single-center, open-label, single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory lymphoma patients after lymphocyte depletion pre-treatment.
The study aims to include patients with CD20/CD30 double-positive relapsed/refractory lymphomas, CD20-positive relapsed/refractory B-cell lymphomas (including patients who have relapsed after anti-CD19-CAR-T cell therapy), and CD30-positive Hodgkin lymphoma. Participants will undergo screening, peripheral blood mononuclear cell (PBMC) collection, and lymphocyte depletion pre-treatment before receiving a single infusion of anti-CD20/CD30-CAR-T cells.
Throughout the study, efficacy assessments will occur at baseline and at 4 weeks post-treatment, and subsequently at 3 months, 6 months, 9 months, and 12 months, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, investigator decision, or voluntary withdrawal (whichever comes first).
Safety evaluations of anti-CD20/CD30-CAR-T cell therapy will be conducted according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) by laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations. Additionally, blood samples will be collected to assess cellular pharmacokinetics and explore the effects of cellular therapy on ferritin, C-reactive protein, and related cytokines.
The study is designed as an exploratory research project, subject to implementation conditions at the research center. Dose escalation during this study phase will follow a traditional "3+3" trial design.
- Conditions
- B Cell Malignancies
- Being tested
- anti-CD20/CD30-CAR-T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD20/CD30-CAR-T CellsBiological
Before cell infusion,researchers may decide, based on necessity, whether to administer prophylactic medication,which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD20/CD30-CAR-T cell infusion,including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesice,etc.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD20/CD30-CAR-T Cells | Experimental | anti-CD20/CD30-CAR-T cell infusion.Infusion doses:The planned infusion doses are follows：the first dose group at 3E5 cells/kg; the second dose group at 1E6 cells/kg; the third dose group at 3E6 cells/kg. Infusion doses refer to the number of CAR-positive cells.
Administration method: anti-CD20/CD30-CAR-T cells are administered intravenously via an infusion pump at approximately 2-5 mL/minute, with a recommended infusion duration of less than 30 minutes. Receives: Biological: anti-CD20/CD30-CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities(DLTs). Safety evlauations are performed in accordance with the NCI-CTCAE version 5.0 standards(Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
Measured: Up to 28 days from CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell MalignanciesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519344
- Sponsor's protocol ID
- CD20/CD30-CN-A2
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Safety and Efficacy of Intravenous Anti-CD20/CD30-CAR-T Cell Infusion in Relapsed/Refractory Lymphoma Patients.
- ClinicalTrials.gov ID
- NCT06519344
- Acronym / sponsor ID
- CD20/CD30-CN-A2
- Conditions
- B Cell Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Jul 2024 (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 single-center,open-label,single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after lymphocyte depletion pre-treatment.
In this study phase,a traditional "3+3"trial design is employed for dose escalation.
Detailed description
This study is a single-center, open-label, single-dose clinical trial of anti-CD20/CD30-CAR-T cell therapy in relapsed/refractory lymphoma patients after lymphocyte depletion pre-treatment.
The study aims to include patients with CD20/CD30 double-positive relapsed/refractory lymphomas, CD20-positive relapsed/refractory B-cell lymphomas (including patients who have relapsed after anti-CD19-CAR-T cell therapy), and CD30-positive Hodgkin lymphoma. Participants will undergo screening, peripheral blood mononuclear cell (PBMC) collection, and lymphocyte depletion pre-treatment before receiving a single infusion of anti-CD20/CD30-CAR-T cells.
Throughout the study, efficacy assessments will occur at baseline and at 4 weeks post-treatment, and subsequently at 3 months, 6 months, 9 months, and 12 months, until disease progression (PD), relapse, change of treatment regimen, death, intolerable toxicity, investigator decision, or voluntary withdrawal (whichever comes first).
Safety evaluations of anti-CD20/CD30-CAR-T cell therapy will be conducted according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) by laboratory tests, 12-lead electrocardiograms, vital signs, and physical examinations. Additionally, blood samples will be collected to assess cellular pharmacokinetics and explore the effects of cellular therapy on ferritin, C-reactive protein, and related cytokines.
The study is designed as an exploratory research project, subject to implementation conditions at the research center. Dose escalation during this study phase will follow a traditional "3+3" trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD20/CD30-CAR-T Cells | Experimental | Biological: anti-CD20/CD30-CAR-T Cellsanti-CD20/CD30-CAR-T cell infusion.Infusion doses:The planned infusion doses are follows：the first dose group at 3E5 cells/kg; the second dose group at 1E6 cells/kg; the third dose group at 3E6 cells/kg. Infusion doses refer to the number of CAR-positive cells. Administration method: anti-CD20/CD30-CAR-T cells are administered intravenously via an infusion pump at approximately 2-5 mL/minute, with a recommended infusion duration of less than 30 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Voluntary participation in the clinical study; complete understanding by self or legally authorized guardian, informed of the study, and signing the Informed Consent Form (ICF); willing and able to comply with all trial procedures.
- Age between 18 and 70 years.
- Patients refractory or relapsed after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation), and unsuitable for other treatment options such as second hematopoietic stem cell transplantation. Refractory/relapsed lymphoma is defined as:
- No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):
- No response to second-line or subsequent therapies:
Key exclusion criteria (26 listed)
- Evidence of central nervous system lymphoma on brain MRI; active primary central nervous system DLBCL, unless CNS involvement has been effectively treated (i.e., participant is asymptomatic) and there has been a local treatment interval of >4 weeks prior to enrollment.
- Active central nervous system diseases such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.
- History of or concurrent malignancies other than CD19+ malignancies.
- Clinically significant cardiac disease, or arrhythmias not controlled by medication.
- Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections requiring intravenous antibiotics; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed.
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 |
|---|---|---|
| anti-CD20/CD30-CAR-T CellsBefore cell infusion,researchers may decide, based on necessity, whether to administer prophylactic medication,which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD20/CD30-CAR-T cell infusion,including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesice,etc. | Biological | anti-CD20/CD30-CAR-T Cells |
Primary outcome
Incidence of dose-limiting toxicity
Time frame: Up to 28 days from CAR-T infusion
The proportion of patients receiving CAR-T cells who encounter dose-limiting toxicities(DLTs). Safety evlauations are performed in accordance with the NCI-CTCAE version 5.0 standards(Cytokine Release Syndrome and neurotoxicity will be graded based on ASTCT/ASBMT grading criteria).
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 25 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for B Cell Malignancies
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
RecruitingPhase 2
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
Not yet recruitingPhase 1
4SCAR19U T Cells Targeting B Cell Malignancies
B Cell Malignancies
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
Aibin Liang principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD20/CD30-CAR-T Cells in people with B Cell Malignancies, run by Shanghai Tongji Hospital, Tongji University School of Medicine.
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 39 inclusion and 26 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: opening soon, as of the sponsor's last update on 25 Jul 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Aibin Liang (+86 21 6611 1019, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (time frame: Up to 28 days from CAR-T infusion). 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 25 Jul 2024.