An interventional study of Therapeutic 4SCAR19 cells in B-cell Malignancies, sponsored by Shenzhen Geno-Immune Medical Institute. Terminated at 1 site in China. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Shenzhen Geno-Immune Medical Institute · Not applicable, Interventional, and Other
Among 46 studies in Leukemia, B-Cell with a site in China — 14 open to participants now, 15 under way, 2 of them phase 3. Leukemia, B-Cell · China.
Among the 46 studies in Leukemia, B-Cell with a site in China, this one is the 5th largest by enrollment, is one of 4 that started in 2025, is one of 6 with no phase, and was the 5th registered.
190 studies on the registry are indexed under Leukemia, B-Cell; 52 are open to participants now.
This study's enrollment of 200 is above the median of 39 across 162 interventional studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →14 of the 46 studies in Leukemia, B-Cell with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 39 Leukemia, B-Cell studies recruiting now, 18 (46%) set no upper age limit and 16 (41%) stop at 75 or younger; 16 take children under 18; 1 take healthy volunteers.
This study: 6 Months and older · all sexes · no healthy volunteers.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 4 started in 2025.
Median enrollment 27 across the 46 interventional studies. Of the 4 that completed or were terminated, 0 (0%) have results posted.
18 of 46 have an industry lead sponsor. The 10 most frequent:
Shenzhen Geno-Immune Medical Institute is the lead sponsor of 70 studies on the registry; 44 are open to participants now.
Shenzhen Geno-Immune Medical Institute has 3 studies filed under Leukemia, B-Cell — fewer than ten, so there is no comparison to draw.
6 of the studies in Leukemia, B-Cell with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03836261Phase 3Acerta Pharma BVStudy of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL | 2027-04-30 |
| NCT05254743Phase 3Loxo Oncology, Inc.A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-10 |
| NCT06355739Zhu XiaofanCD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+ | 2026-12-01 |
| NCT07511426The First Affiliated Hospital of Soochow UniversityU96-CAR-T-Cells For R/R B-ALL | 2027-01-07 |
| NCT06834529Affiliated Hospital to Academy of Military Medical SciencesCAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma | 2027-01-31 |
Among the 46 studies in Leukemia, B-Cell with a site in China, from their registry updates:
The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Background:
T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. Recent successes suggest that increased costimulatory signaling in the CAR design is critical for long term efficacy. Activation of T cell response from large tumor burden may induce a severe response. To increase safety, a novel design using an inducible caspase 9 fusion gene has been incorporated in the CAR gene. A 4th generation CAR lentiviral vector (4SCAR) carrying T cell costimulatory signals for CD28/CD27 plus an inducible apoptotic caspase 9 gene has been established. The study aims to evaluate the activities of a new CAR gene-modified T cells targeting CD19-positive tumors based on a CD19-specific single chain gene constructed 4SCAR (4SCAR19).
Objective:
To evaluate safety and efficacy of administrating 4SCAR19 T cells to patients with CD19 positive B cell malignancies following a cyclophosphamide/fludarabine based conditioning regimen.
Eligibility:
Patients older than 6-month-old with CD19 positive B cells malignancies that have recurred after or refractory to standard therapy and is deemed incurable using standard treatment.
Design:
Participants will be screened based on cancer cell phenotype analyzed using flow cytometry or immunohistochemical staining methods.
Peripheral blood mononuclear cells (PBMC) will be obtained through apheresis, and T cells will be activated and modified to express the 4SCAR19 gene.
On Day -5 to -7, PBMC will be activated and enriched for T cells, which will be followed by 4SCAR19 lentiviral transduction. The total cell preparation time is approximately 5-7 days.
Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accommodate the modified CAR T cells. The preparative regimen will be based on patient immune condition and consistent with standard chemotherapy conditioning regimen.
Participants will receive an infusion of the modified 4SCAR19 T cells and closely followed up for treatment-related responses.
Participants will be continuously monitored for CAR T cells and clinical responses at present timeline.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
Genetic: Therapeutic 4SCAR19 cells
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events
physiological parameter (for safety, measuring cytokine response, fever, symptoms)
Time frame: 24 weeks
Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B cell malignancies
scale of CAR copies and leukemic cell burden (for efficacy)
Time frame: 1 year
Plan to share: Undecided
Ran from May 2025 to primary completion in Jul 2026, 14 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Shenzhen Geno-Immune Medical Institute