NCT04003168

Brief Summary

To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Jul 2019

Typical duration for phase_1 multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

June 24, 2019

Last Update Submit

February 25, 2021

Conditions

Multiple Myeloma

Keywords

BCMACAR-Tmultiple myelomaRelapsed/Refractory

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0

    28 days post infusion

Secondary Outcomes (10)

  • Concentration of Anti-BCMA CAR T Cells in blood

    2 years post infusion

  • Concentration of Anti-BCMA CAR T Cells in bone marrow

    2 years post infusion

  • Pharmacodynamics (Levels of Cytokines in Serum)

    2 years post infusion

  • Pharmacodynamics (Content of clonal plasma cells in bone marrow)

    2 years post infusion

  • Overall response rate (ORR) after administration

    3 months post infusion

  • +5 more secondary outcomes

Study Arms (1)

Human BCMA targeted T Cells Injection

EXPERIMENTAL

A single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10\^6 CAR T +cells/kg. The classic "3+3" dose escalation will be applied.

Drug: Human BCMA targeted T Cells Injection

Interventions

Human BCMA targeted T Cells InjectionDRUG

Autologous genetically modified anti-BCMA CAR transduced T cells

Human BCMA targeted T Cells Injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures;
  • to 70 Years Old, Male and female;
  • Expected survival \> 12 weeks;
  • Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
  • Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
  • One of the following indicators is satisfied:
  • Serum M protein IgG ≥ 10 g/L, or IgA \> 10 mg/L, or IgD \> 5 mg/L;
  • Urine M protein ≥ 200 mg/24h;
  • Serum free light chain ≥ 100 mg/L;
  • Patients with relapsed/refractory multiple myeloma. Relapsed is defined as:
  • Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators, and have disease progression within 60 days of the latest treatment ; Refractory is defined as: Patients who achieved remission in the piror therapies, have disease progression within 60 days, or after the latest therapy.
  • Those who relapse 90 days after stem cell transplantation
  • ECOG score 0-1;
  • Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
  • +4 more criteria

You may not qualify if:

  • Accompanied by other uncontrolled malignancies;
  • Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis primary screening antibody positive;
  • Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease with poor drug control;
  • Patients who are accounted to be not appropriate for this trail by investigator;
  • Pregnant or lactating, or planning to have a pregnancy during or within 1 year after treatment;
  • Received CAR-T treatment or other gene therapies before enrollment;
  • Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements;
  • Have had severe immediate hypersensitivity reactions to any drugs used in this research;
  • The presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
  • In the past two years, the terminal organ was damaged due to autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
  • Have a history of central nervous system (CNS) disease, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (1)

  • Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.

    PMID: 36536403DERIVED

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hongliang Fang, doctor

CONTACT

021-58552006fanghongliang@dashengbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

July 1, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2024

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

CN(3)