Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

December 10, 2019 updated by: LiFei,M.D., Ph.D., The First Affiliated Hospital of Nanchang University

Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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 Contact

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:

  1. Male or female aged 18-70 years old
  2. Estimated Survival time > 12 weeks
  3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
  4. Chemotherapy failure or recurrent multiple myeloma
  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 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: Mixed BCMA/CD19 CAR-T Transfer
Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts
Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cells
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 2 year
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
2 year
minimal residual disease（MRD）
Time Frame: 2 year
Assessment of MRD negative overall response rate at 3 months of treatment
2 year
Progression-free survival (PFS)
Time Frame: 2 year
Assessment of Progression-free survival (PFS) at 6 months of treatment
2 year
Overall survival (OS)
Time Frame: 2 year
Assessment of overall survival (OS) at 6 months of treatment
2 year

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 year
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
2 year

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)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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