AzTrials
AzTrials

Relapsed/Refractory LymphomaEarly Phase 1NCT06532643

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

A Early Phase 1 study testing anti-CD20/CD30-CAR-T cells, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Lymphoma, run by Shanghai First Song Biotechnology Co., LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Relapsed/Refractory Lymphoma
What is being tested?
anti-CD20/CD30-CAR-T cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
24 Aug 2023to 1 Sep 2026
Phase
Early 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 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria to be eligible for the study:
  • Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.
  • Age ≥ 14 years and < 70 years.
  • Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant. The definitions of relapsed/refractory lymphoma include one of the following situations:
  • No response to first-line treatment (primary refractory disease, excluding participants intolerant to first-line treatments).
  • Disease progression (PD) as assessed after first-line treatment.
Show all 40Show fewer
  • Best efficacy of first-line treatment (e.g., 4 cycles of RCHOP) as stable disease (SD), with the duration of SD not exceeding 6 months after the last dose.
  • No response to second-line or more treatments.
  • PD being the best response to the most recent treatment.
  • Best efficacy of the last line of treatment as SD after at least 2 cycles, with the duration of SD not exceeding 6 months after the last dose.
  • Refractory after autologous stem cell transplant (ASCT).
  • Disease progression or relapse ≤ 12 months post-ASCT (relapsed patients must have biopsy-proven relapse).
  • If salvage treatment is administered after ASCT, the subjects must not have had a response or relapse after the last line of treatment.
  • Relapsed or refractory disease after two or more lines of systemic treatment.
  • Lymphoma patients must have target antigens meeting the following criteria:
  • CD20/CD30 double-positive expressing lymphoma.
  • Relapse after receiving anti-CD19-CAR-T cell therapy, with CD20 positive lymphoma.
  • CD20 positive lymphoma that has not previously received anti-CD19-CAR-T cell therapy.
  • CD30 positive Hodgkin lymphoma.
  • Subtypes of lymphoma included for enrollment are as follows:
  • DLBCL-NOS (diffuse large B-cell Lymphoma, not otherwise specified)
  • Primary mediastinal B-cell lymphoma (PMBCL)
  • Transformed follicular lymphoma (TFL), previously treated for follicular lymphoma and then transformed to refractory DLBCL
  • 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 apheresis) and no other contraindications for blood cell separation.
  • Laboratory tests during screening must meet the following requirements, and the hematological assessment must not have received cell growth factors within 7 days (long-acting colony-stimulating factors (G-CSF/PEG-CSF) require a 2-week interval) or platelet transfusions:
  • Absolute neutrophil count ≥ 1.0×10^9/L.
  • Hemoglobin ≥ 60 g/L (without red blood cell transfusion in the last 7 days).
  • Platelets ≥ 50×10^9/L (unrestricted for CLL indications).
  • Total bilirubin ≤ 1.5× the upper limit of normal (ULN); or total bilirubin ≤ 3× ULN when the tumor invades liver tissue.
  • Aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.5×ULN, with AST/ALT ≤ 5×ULN when the tumor invades liver tissue.
  • Creatinine < 1.5× ULN and estimated creatinine clearance ≥ 60 mL/min.
  • Ejection fraction ≥ 45%, with echocardiogram (ECHO) confirming no pericardial effusion (excluding small or physiological amounts), and electrocardiogram results with no clinical significance.
  • 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 have been postmenopausal for at least 2 years are not considered of childbearing potential).

Who cannot join

  • Subjects are not eligible to participate in this study if they meet any of the following criteria:
  • MRI of the brain shows evidence of central nervous system lymphoma; active primary central nervous system DLBL, unless central nervous system involvement has been effectively treated (i.e., participant is asymptomatic), and there has been more than a 4-week gap since local treatment.
  • 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 diagnosis of malignancies other than CD19+ malignancies.
  • Clinically significant heart disease or arrhythmias that cannot be controlled with medication.
  • Presence or suspicion of fungal, bacterial, viral, or other infections that are uncontrolled or require intravenous antibiotics for treatment; uncomplicated urinary tract infections and uncomplicated bacterial pharyngitis are allowed.
Show all 33Show fewer
  • Positive for hepatitis B (HBsAg positive and HBV DNA >1000 copies/mL) and hepatitis C (positive for HCV antibodies); syphilis or human immunodeficiency virus (HIV) infection.
  • Presence of any indwelling catheter or drainage tube (such as percutaneous nephrostomy, indwelling Foley catheter, bile drainage tube, or pleural/peritoneal/pericardial catheter); use of specialized central venous access devices like Port-A-Cath® or Hickman® catheters is allowed.
  • History of using any of the following medications:
  • Lenalidomide within 1 day before the apheresis.
  • Idelalisib (oral PI3Kδ inhibitor) within 2 days before the apheresis.
  • Short-acting targeted therapy (like tyrosine kinase inhibitors) within 72 hours before the apheresis.
  • Venetoclax (BCL-2 inhibitor) within 4 days before the apheresis.
  • Long-acting growth factors (like pegylated filgrastim) within 14 days before the apheresis, or short-acting growth factors or mobilization agents (like G-CSF/filgrastim, plerixafor) within 5 days before the apheresis.
  • Pharmacological doses of corticosteroids (>5mg/day of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 7 days before enrollment.
  • Radiation therapy within 14 days before enrollment.
  • Systemic cytotoxic drugs, including low-dose maintenance chemotherapy (cyclophosphamide, ifosfamide, bendamustine, methotrexate, or mercaptopurine, vincristine, etc.), within 14 days before enrollment. If bridging therapy is given after apheresis, there should be more than a 7-day gap between bridging therapy and CAR-T cell infusion.
  • Anti-PD1 or anti-PDL1 within 4 weeks prior to enrollment.
  • Live vaccines within 4 weeks prior to enrollment.
  • Donor lymphocyte infusion (DLI) within 4 weeks prior to enrollment.
  • Immune stimulation or immunosuppressive therapy (like interferon-α, interferon-β, IL-2, etanercept, infliximab, tacrolimus, cyclosporine, or mycophenolate mofetil) within 4 weeks prior to enrollment.
  • Use of clofarabine or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.
  • Active graft-versus-host disease (GVHD) rated ≥2 on the CIBMTR acute GVHD grading system or requires systemic steroids at doses greater than physiological levels.
  • A history of autoimmune diseases in the past 2 years (like Crohn's disease, rheumatoid arthritis, or systemic lupus erythematosus) that has caused damage to end organs or requires systemic immunosuppression/systemic disease-modifying agents.
  • A history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant heart diseases within the 12 months prior to enrollment.
  • A history of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, or Schwachman-Diamond syndrome.
  • A history of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation in the 6 months before enrollment. Subjects need to be on preventive anticoagulant medication.
  • A history of other malignancies (except for non-melanoma skin cancer, in situ breast/cervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).
  • Use of other investigational medicinal products within 30 days prior to screening.
  • Pregnant or breastfeeding women of childbearing age. Women who have undergone surgical sterilization or are postmenopausal for at least 2 years are not considered of childbearing potential.
  • Male and female subjects unwilling to practice contraception from the time they agree to treatment until 12 months after completing the lymphodepleting chemotherapy or CAR-T infusion (whichever is longer).
  • Any medical activities that could interfere with the safety or efficacy evaluation of the study treatment.
  • In the judgment of the investigator, subjects are unlikely to complete all required study visits or procedures (including follow-ups) or to comply with the study participation requirements.

Trial locations and contacts

1 site in 1 country.

Huaying Ruan contact

+86-021-50565587

reta.r@triarmbio.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Jian Ge, MD, +86-0551-62923653, gejian52@163.com

    Jian Ge, MD

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Autologous Anti-CD20/CD30 Chimeric Antigen Receptor T Cells (anti-CD20/CD30 CAR-T Cells) in Subjects with Relapsed/Refractory Lymphoma

This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.

Read the detailed description

The study will enroll subjects with CD20 and CD30-positive lymphoma, CD20-positive lymphoma, or CD30-positive Hodgkin lymphoma. Subjects will receive a single infusion of anti-CD20/CD30-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy. Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from the National Cancer Institute. Safety of anti-CD20/CD30-CAR-T cell therapy will be evaluated through laboratory tests, including 12-lead electrocardiograms, vital sign checks, etc. Additionally, blood samples will be collected from subjects to study cellular pharmacokinetics and explore the effects of cell therapy on ferritin, C-reactive protein, and related cytokines.

Being tested
anti-CD20/CD30-CAR-T cells, Fludarabine, Cyclophosphamide
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD20/CD30-CAR-T cellsGenetic

    Each subject will be infused with single dose of anti-CD20/CD30-CAR-T cells. A classic "3+3" dose escalation will be employed.

  • FludarabineDrug

    Fludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.

  • CyclophosphamideDrug

    Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.

Study groups in NCT06532643
Study groupRoleWhat they receive
Anti-CD20/CD30-CAR-T Cell TherapyExperimentalInvestigational product: anti-CD20/CD30-CAR-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of anti-CD20/CD30-CAR-T cells.
Receives: Genetic: anti-CD20/CD30-CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerance

    Incidence of dose-limiting toxicity (DLT)

    Measured: 28 days after infusion of anti-CD20/CD30-CAR-T cells

  2. Manufacturing feasibility

    Percentage of subjects for whom the required dose of anti-CD20/CD30-CAR-T cells can be successfully manufactured.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start24 Aug 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532643
Sponsor's protocol ID
CD20/CD30-CN-A1
Status last verified
Sep 2024
First submitted
30 Jul 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-CD20/CD30-CAR-T cells, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Lymphoma, run by Shanghai First Song Biotechnology 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 40 inclusion and 33 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 19 Sep 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?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huaying Ruan (+86-021-50565587, reta.r@triarmbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerance (time frame: 28 days after infusion of anti-CD20/CD30-CAR-T cells). 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?

On the ClinicalTrials.gov record for NCT06532643.

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 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in