CClinicalTrials.gg
Status unknownNCT03685786Updated Dec 7, 2018

CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

A Phase 1 interventional study of CART19 cell and auto-HSCT in Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, B-Cell, sponsored by Shenzhen Second People's Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-07.

Sponsored by Shenzhen Second People's Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2018, registered Sep 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 75 Years
Sex
All
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Study summary

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Read the detailed description

The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).

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Conditions studied

  • Leukemia, Lymphocytic, Acute, B-Cell
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, B-Cell
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Shenzhen Second People's Hospital is the lead sponsor of 48 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma,who have 0.01%≤MRD\<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:
  1. AST and ALT ≤ 3 times upper limit of normal range for age,
  2. Serum creatinine ≤ 1.6 mg/dl,
  3. Direct bilirubin ≤2.0 mg/dl,
  4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
  5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion criteria

Exclusion Criteria:

  1. Active, uncontrolled infection
  2. Active hepatitis B or hepatitis C
  3. HIV Infection
  4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
  5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
  6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
  7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental: CART19 cell and auto-HSCT

    CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

    Biological: CART19 cell and auto-HSCT

Interventions

  • BiologicalCART19 cell and auto-HSCT

    Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

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What researchers measure

Primary outcomes

  1. CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

    The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment

    Time frame: day 28

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021. PubMed 35126471 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03685786
Lead sponsor
Shenzhen Second People's Hospital
Responsible party
Sponsor
First posted
Sep 26, 2018
Start date
Jun 1, 2018
Primary completion
Jun 2, 2021 (estimated)
Completion
Sep 2, 2021 (estimated)
Last update
Dec 7, 2018

Study contacts

Weihong Chen, M.D., Ph.D.
Contact
whitney-cindy@hotmail.com
0086-755-83366388 ext. 8199
Xin Du, M.D., Ph.D.
Contact
duxingz@medmail.com.cn
0086-755-83366388 ext. 8197
Weihong Chen, M.D., Ph.D.
principal investigator · The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xin Du, M.D., Ph.D.
principal investigator · The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xiaochun Wan, Ph.D.
principal investigator · Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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