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

December 11, 2019 updated by: LiFei, The First Affiliated Hospital of Nanchang University

Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nangchang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-CD19 CAR-T
Biological: Anti-CD19 CAR-T
1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall responce rate(ORR)
Time Frame: 2 years
Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
2 years
Overall survival (OS)
Time Frame: 2 years
Assessment of OS(Overall survival) at 6 months of treatment
2 years
Progression-free survival (PFS)
Time Frame: 2 years
Assessment of PFS(Progression-free survival ) at 6 months of treatment
2 years
minimal residual disease（MRD）
Time Frame: 2 years
Assessment of MRD negative overall response rate at 3 months of treatment
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (incidence of adverse events defined as dose-limited toxicity)
Time Frame: Study treatment until Week 24
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Study treatment until Week 24
Expression of CD19 CART cells
Time Frame: 2 years
Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
2 years
Detection of CD19 CART cells
Time Frame: 2 years
Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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