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B-Cell MalignancyEarly Phase 1NCT06532630

Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies

A Early Phase 1 study testing Anti-CD19-CAR-T cells, Fludarabine and Cyclophosphamide in people with B-Cell Malignancy, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
B-Cell Malignancy
What is being tested?
Anti-CD19-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

  • Subjects must meet all of the following criteria for inclusion in the study:
  • Patient able to provide written informed consent; parent or guardian of minor patient able to provide written informed consent; ability and willingness to adhere to the study visit schedule and all protocol requirements.
  • 14 - 70 years old.
  • Relapsed/refractory disease after standard treatment (including allogeneic/autologous hematopoietic stem cell transplantation) and not eligible for other treatment options such as a second hematopoietic stem cell transplant.
  • Relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:
  • Primary refractory disease.
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  • Relapsed within 12 months after first remission.
  • Relapsed or refractory after two or more lines of systemic therapy.
  • Relapsed or refractory post allogeneic SCT. i. more than 100 days from the transplantation at the time of enrollment. ii. not receiving immunosuppressive drugs for 4 weeks prior to enrollment (≤5 mg prednisone or equivalent is allowed).
  • Ph+ B-cell ALL are eligible if they are intolerant or ineligible for tyrosine kinase inhibitor (TKI) therapy or have relapse/refractory disease after at least two different TKI treatments.
  • Relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) is defined as one of the following:
  • No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):
  • PD is the best response after first-line therapy.
  • Best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) is stable disease (SD), with rapid progression in 6 months.
  • No response to second or subsequent lines of therapy:
  • PD is the best response to last regimen.
  • Best response after at least 2 cycles of the last-line therapy is SD, with rapid progression in 6 months.
  • Refractory post-autologous stem cell transplant (ASCT):
  • Disease progression or relapse within 12 months (relapse must be biopsy-proven).
  • If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
  • Relapsed or refractory after two or more lines of systemic therapy.
  • Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening
  • Relapsed/refractory NHL as one of the following subtypes:
  • DLBCL-NOS B. Primary mediastinal large B-cell lymphoma (PMBCL) C. Transformed follicular lymphoma (TFL) following prior chemotherapy for follicular lymphoma and subsequent transformation to DLBCL with refractory disease.
  • Mantle cell lymphoma E. High-grade B-cell lymphoma F. CLL/SLL
  • ECOG performance status ≤2.
  • Life expectancy ≥ 12 weeks.
  • Adequate venous access (for apheresis) and no other contraindications for blood cell separation.
  • Subjects must meet the following laboratory criteria at screening, and they should not have received any growth factors within the 7 days prior to the hematologic assessment:
  • Absolute neutrophil count ≥1.0×10^9/L. For subjects with ALL, specific criteria will be determined by the investigator.
  • Hemoglobin ≥60 g/L (without RBC transfusion within 14 days). C. Platelets ≥50×10^9/L. For subjects with ALL, specific criteria will be determined by the investigator.
  • Absolute lymphocyte count (ALC) ≥0.5×10^9/L. If the total lymphocyte count is insufficient with a high proportion of T cells, the investigator may discuss with the sponsor.
  • Total bilirubin <1.5×ULN; if liver involved, total bilirubin <3.0×ULN is allowed.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; if liver involved, ALT/AST ≤5×ULN is allowed.
  • Creatinine <1.5×ULN and estimated creatinine clearance ≥60 mL/min.
  • Cardiac ejection fraction (EF) ≥45% with no clinically significant findings on electrocardiogram.
  • Baseline oxygen saturation >92% on room air.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential).

Who cannot join

  • If patients meet any of the following conditions, they cannot participate in this trial:
  • Central nervous system (CNS) involvement in ALL and clinically significant neurological changes (CNS-2 and CNS-3):
  • CNS-3, defined as detectable tumor cells in cerebrospinal fluid (CSF) with ≥ 5 white blood cells (WBCs) /mm3.
  • CNS-2, defined as detectable tumor cells in CSF with <5 WBCs /mm3. Note: Subjects with CNS-1 (no detectable tumor cells in CSF) or CNS-2 without evidence of clinically significant neurological changes are eligible for this study.
  • CNS lymphoma confirmed by MRI; active CNS DLBL unless CNS involvement has been effectively treated (i.e., asymptomatic) and a local treatment interval of > 4 weeks prior to enrollment.
  • Active CNS diseases such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the central nervous system.
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  • Any malignancies other than CD19+ malignancies.
  • Clinically significant heart disease or arrhythmias not controlled by medication.
  • Ongoing or suspected fungal, bacterial, viral, or other infections that are uncontrolled or require intravenous antibiotic therapy; simple urinary tract infections and simple bacterial pharyngitis are allowed.
  • Hepatitis B (positive for hepatitis B surface antigen and hepatitis B DNA >1000 copies/mL) and hepatitis C (positive for hepatitis C antibodies); syphilis, human immunodeficiency virus (HIV) infection.
  • Presence of any indwelling or drainage catheter (e.g., percutaneous nephrostomy, indwelling Foley catheter, biliary drainage catheter, pleural/peritoneal/pericardial drainage catheter); the use of dedicated central venous access devices such as Port-A-Cath® or Hickman® catheters is allowed.
  • Prior use of the following:
  • CD19-targeted therapy.
  • Chlorambucil or bendamustine within 3 months before enrollment, or PEG-asparaginase within 3 weeks before enrollment.
  • live vaccines within 4 weeks before enrollment.
  • Donor lymphocyte infusions (DLI) within 4 weeks before enrollment.
  • Medications for graft-versus-host disease (GVHD) treatment within 4 weeks before enrollment, such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, or siltuximab, or use of immunosuppressive antibodies (anti-CD20, anti-tumor necrosis factor, anti-interleukin 6, or anti-interleukin 6 receptor) within 4 weeks before enrollment.
  • Immunostimulatory or immunosuppressive therapy within 4 weeks before enrollment, including interferon-α, interferon-β, IL-2, lenalidomide, efalizumab, alemtuzumab, tocilizumab, cyclosporine, or thalidomide.
  • Anti-PD-1/anti-PD-L1 therapy within 4 weeks before enrollment.
  • Systemic cytotoxic chemotherapy within 14 days before enrollment, including daily or weekly low-dose maintenance chemotherapy (e.g., cyclophosphamide, ifosfamide, bendamustine, chlorambucil, melphalan, or vincristine).
  • Long-acting growth factors (e.g., pegfilgrastim) within 14 days before apheresis or short-acting growth factors within 5 days before apheresis or mobilization agents (e.g., filgrastim/pegfilgrastim, plerixafor) within 5 days before apheresis.
  • Radiation therapy within 14 days before enrollment.
  • Pharmacological doses of corticosteroids (>5 mg/day prednisone or equivalent) or other immunosuppressive drugs within 7 days before enrollment.
  • Venetoclax (BCL-2 inhibitor) within 4 days before apheresis.
  • Short-acting targeted therapy (e.g., tyrosine kinase inhibitors) within 72 hours before apheresis.
  • Idelalisib (oral PI3Kδ inhibitor) within 2 days before apheresis.
  • Lenalidomide within 1 day before enrollment.
  • ≥ Grade 2 graft-versus-host disease (GVHD) per the CIBMTR grading system or requiring systemic corticosteroid treatment exceeding physiological doses.
  • A history of autoimmune diseases in the past 2 years, such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, leading to end-organ damage or requiring systemic immunosuppression or disease-modifying agents.
  • A history of heart attack, cardiac catheterization or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment.
  • A history of genetic syndrome with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Schwachman-Diamond syndrome, etc.
  • Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment. Subjects need to be on prophylactic anticoagulation.
  • A history of or currently having other malignant tumors (excluding skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated in the past five years but are effectively controlled).
  • Use of other investigational medicinal products within 30 days before screening.
  • Pregnant, planning to become pregnant, or breastfeeding in reproductive-aged women. Women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of reproductive potential.
  • Male and female subjects unwilling to practice contraception from the time of agreeing to treatment until 12 months after completion of conditioning chemotherapy or CAR-T infusion.
  • Any past medical history that may interfere with the safety of the study treatment or the evaluation of efficacy.
  • Based on the investigator's judgment, subjects are unlikely to complete all the study visits or procedures required by the protocol.
  • Previous use of any CAR-T cell product or other gene-modified T cell therapy.

Trial locations and contacts

1 site in 1 country.

Long contact

055162923653

drlong1111@163.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 Evaluating the Safety and Efficacy of Anti-CD19-CAR-T Cell Therapy in Subjects With Relapsed/Refractory B Cell Malignancies

This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies.

This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.

Read the detailed description

This study will enroll subjects with CD19-positive relapsed/refractory B-cell malignancies. The effectiveness assessments for anti-CD19-CAR-T cell therapy is evaluated according to international criteria including the 2018 Lugano Classification. Toxicity is evaluated based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from the National Cancer Institute. The safety of anti-CD19-CAR-T cell therapy will be evaluated through laboratory tests, 12-lead EKGs, and vital signs monitoring. Additionally, blood samples from subjects will be collected to study cellular metabolism and explore the effects of cell therapy on ferritin, C-reactive protein, and related cytokines.

Being tested
Anti-CD19-CAR-T cells, Fludarabine, Cyclophosphamide

What participants receive

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

  • Anti-CD19-CAR-T cellsGenetic

    Each subject will be infused with single dose of anti-CD19-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 anti-CD19-CAR-T cells infusion.

  • CyclophosphamideDrug

    Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to anti-CD19-CAR-T cells infusion.

Study groups in NCT06532630
Study groupRoleWhat they receive
Anti-CD19-CAR-T cell therapyExperimentalInvestigational product: anti-CD19-CAR-T cells. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to anti-CD19-CAR-T cells infusion.
Receives: Genetic: Anti-CD19-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 anti-CD19-CAR-T cells infusion

  2. Manufacturing feasibility

    Percentage of subjects for whom the required dose of anti-CD19-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
NCT06532630
Sponsor's protocol ID
CD19-CN-A5
Status last verified
Jul 2024
First submitted
30 Jul 2024
Last updated
28 Feb 2025
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-CD19-CAR-T cells, Fludarabine and Cyclophosphamide in people with B-Cell Malignancy, 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 38 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2025. 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 Long (055162923653, drlong1111@163.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 anti-CD19-CAR-T cells infusion). 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 NCT06532630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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