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Status unknownNCT03258047Updated Feb 15, 2019

Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

A Phase 2 interventional study of CAR-T in B Cell Lymphoma, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

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Conditions studied

  • B Cell Lymphoma
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age≥18 years, male or female;
  2. Karnofsky≥60%;
  3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
  4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
  5. Patients have had more than 2 combined chemotherapy regimens;
  6. Creatinin \<2.5mg/dL;ALT/AST level \<3 times of the maximum of normal range; bilirubin\<3mg/dL;
  7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;
  8. Patient that could understand and is willing to sign the written consent;
  9. Fertile female patient should be willing to take contraceptive measures.
  10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion criteria

Exclusion Criteria:

  1. Patients who need ≥15mg prednisone daily due to any cause;
  2. Patients with autoimmune disease and need immunosuppressor treatment;
  3. Serum creatinin>2.5 mg/dL;serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
  4. FEV1\<2 L,diffusion capacity for carbon monoxide of lung (DLCO) \<40%;
  5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction\<35%;
  6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
  7. Patients that have previously received gene therapy of any kind;
  8. Obvious clinical encephalopathy or novel neuron function damage;
  9. Patients with active infection;
  10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
  11. Patients who had allergic history to agents of the similar structure as CAR-T;
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Study design

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

Study arms

  • Experimental
    CAR-T treatment

    In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

    Combination Product: CAR-T

Interventions

  • Combination productCAR-T

    CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

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What researchers measure

Primary outcomes

  1. complete remission rate

    complete remission rate after treated by CAR-T therapy

    Time frame: every 3 months until 20 months after the last patient's enrollment

Secondary outcomes

  1. progression free survival

    from date of inclusion to date of progression, relapse, or death from any cause

    Time frame: from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment

  2. overall survival

    from the date of inclusion to date of death, irrespective of cause

    Time frame: 20 months after the last patient's enrollment

  3. adverse events

    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

    Time frame: from the date of the start of treatment to 20 months after last patient's enrollment

  4. duration of the modified T cells by CAR-T in the patients

    time from re-transfusion to date when the modified T cells become non-detectable.

    Time frame: from the date of re-transfusison to 20 months after last patient's enrollment

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Study locations

1 site
  • The first affiliated hospital of Zhejiang University
    Hangzhou, Zhejiang 310000, China
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References and documents

Individual participant data

Plan to share: Yes — All the data would be available on the corresponding website of the leading research center.

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03258047
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Wenbin Qian (Doctor, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
Aug 22, 2017
Start date
Sep 15, 2017
Primary completion
Jan 13, 2019
Completion
Jul 30, 2019 (estimated)
Last update
Feb 15, 2019

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 Feb 2019. You cannot join it, but the record below documents what was studied.

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