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Status unknownNCT04196205Updated Dec 12, 2019

Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas

A Phase 1/2 interventional study of Anti-CD19 CAR-T in Acute Lymphoblastic Leukemia ,Lymphomas, sponsored by The First Affiliated Hospital of Nanchang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by The First Affiliated Hospital of Nanchang University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.

Read the detailed description

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.

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Conditions studied

  • Acute Lymphoblastic Leukemia ,Lymphomas

Keywords

  • acute lymphoblastic leukemia ;Lymphomas
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In context

Lead sponsor

The First Affiliated Hospital of Nanchang University is the lead sponsor of 28 studies on the registry; 15 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ,and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment \< 2 years, The specific requirements are as follows:

  1. Male or female aged 18-70 years old ;
  2. Estimated Survival time > 12 weeks;
  3. Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
  4. Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
  5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level;
  6. Bilirubin\<2.0mg/dl;
  7. Karnofsky Performance Status>50% at the time of screening;
  8. Adequate pulmonary, renal, hepatic, and cardiac function;
  9. Fail in autologous or allogenic haemopoietic stem cell transplantation;
  10. Not suitable for stem cell transplantation conditions or abandoned due to conditions;
  11. Free of leukocytes removal contraindications;
  12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.

Exclusion Criteria:

  1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
  2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
  3. The patient is an active hepatitis B or hepatitis C infection;
  4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
  5. Abnormal vital signs;
  6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
  7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
  8. General infection or local severe infection, or other infection that is not controlled;
  9. Dysfunction in lung, heart, kidney and brain;
  10. Severe autoimmune diseases;
  11. Other symptoms that are not applicable for CAR-T.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Anti-CD19 CAR-T

    Anti-CD19 CAR-T

    Biological: Anti-CD19 CAR-T

Interventions

  • BiologicalAnti-CD19 CAR-T

    1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh

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What researchers measure

Primary outcomes

  1. Overall responce rate(ORR)

    Assessment of ORR (ORR = CR+PR ) at 2 months of treatment

    Time frame: 2 years

  2. Overall survival (OS)

    Assessment of OS(Overall survival) at 6 months of treatment

    Time frame: 2 years

  3. Progression-free survival (PFS)

    Assessment of PFS(Progression-free survival ) at 6 months of treatment

    Time frame: 2 years

  4. minimal residual disease(MRD)

    Assessment of MRD negative overall response rate at 3 months of treatment

    Time frame: 2 years

Secondary outcomes

  1. Safety (incidence of adverse events defined as dose-limited toxicity)

    Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.

    Time frame: Study treatment until Week 24

  2. Expression of CD19 CART cells

    Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.

    Time frame: 2 years

  3. Detection of CD19 CART cells

    Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Nangchang University
    Nanchang, Jiangxi 330006, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, 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
NCT04196205
Lead sponsor
The First Affiliated Hospital of Nanchang University
Responsible party
LiFei (M.D.,Ph.D., The First Affiliated Hospital of Nanchang University) — Principal investigator
First posted
Dec 12, 2019
Start date
Dec 1, 2019 (estimated)
Primary completion
Aug 1, 2020 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Dec 12, 2019

Study contacts

Fei Li, M.D., Ph.D.
Contact
yx021021@sina.com
+86-139-7003-8386

Oversight

Data monitoring committee
Yes
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 2019. You cannot join it, but the record below documents what was studied.

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