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Status unknownNCT02846584Updated Sep 7, 2016

a Clinical Research of Sequential CAR-T Bridging HSCT in the Treatment of Relapse/Refractory B-cell Malignancies

A Phase 2 interventional study of CD19 or CD20 CAR T cells briging HSCT in Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma,Malignant, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.

Sponsored by Southwest Hospital, China · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
14 Years to 75 Years
Sex
All
01

Study summary

The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.

Read the detailed description

The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes.

However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.

02

Conditions studied

  • Lymphoma, Large B-Cell, Diffuse
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma,Malignant

Keywords

  • CAR T
  • HSCT
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

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

04

Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. CD19-expressing or CD20-expressing relapsed or refractory B cell malignancies after at least one standard chemotherapy and one salvage regimen.According to current traditional therapies, there must be no available alternative curative therapies.
  2. Patients enrolled must have an evaluated score above 60 with KPS.
  3. Expected survival time of patients enrolled is over 3 months.
  4. Gender is not limited, age from 14 years to 75 years.
  5. Patients must have 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.
  6. Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
  7. Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy: CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs; CNS 2, defined as presence of \< 5/uL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm CNS3 with marrow disease who has failed salvage systemic and intensive IT chemotherapy (and therefore not eligible for radiation)
  8. Patients with isolated CNS relapse will be eligible if they have previously been treated with cranial radiation (at least 1800 cGy).
  9. Ability to give informed consent.
  10. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
  11. Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
  12. Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
  13. Patients with history of allogeneic stem cell transplantation are eligible if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
  14. Patients volunteer to participate in the research.

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria are not eligible for participation in the study:
  1. Patients are evaluated below 50 scores with KPS.
  2. Evident signs suggesting that patients are potentially allergic to cytokines.
  3. Frequent infection history and recent infection is uncontrolled.
  4. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
  5. Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
  6. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
  7. Pregnancy and nursing females. HIV infection.
  8. Active hepatitis B or active hepatitis C.
  9. Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
  10. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
  11. Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.
  12. Other situations we think not eligible for participation in the research.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CD19 or CD20 CAR T cells briging HSCT

    lentiviral transfection and transfuse anti-CD19 or anti-CD20 CAR T cells into patients. Six months later, select appropriate patients to transplant hemopoietic stem cells.

    Biological: CD19 or CD20 CAR T cells briging HSCT

Interventions

  • BiologicalCD19 or CD20 CAR T cells briging HSCT

    Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells.

06

What researchers measure

Primary outcomes

  1. Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells

    Time frame: 2 years

Secondary outcomes

  1. Treatment response rate of anti-CD19 CAR T cell infusion

    Time frame: 4 weeks

  2. Number of patients with adverse events

    Time frame: 2 years

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Study locations

1 site
  • Southwest Hospital of Third Millitary Medical University
    Chongqing, Chongqing 400000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02846584
Lead sponsor
Southwest Hospital, China
Responsible party
Jieping Chen (Head of Hematology Department, Southwest Hospital, China) — Principal investigator
First posted
Jul 27, 2016
Start date
Jul 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Sep 7, 2016

Study contacts

Jieping Chen, MD,PhD
principal investigator · Southwest Hospital, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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