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BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156269
Recruitment Status : Unknown
Verified January 2019 by iCell Gene Therapeutics.
Recruitment status was:  Recruiting
First Posted : November 7, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Peking University Shenzhen Hospital
Chengdu Military General Hospital
iCAR Bio Therapeutics Ltd.
Information provided by (Responsible Party):
iCell Gene Therapeutics

Study Description
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Brief Summary:
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: BCMA-CS1 cCAR T cells Early Phase 1

Detailed Description:

BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7).

The use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: BCMA-CD33 cCAR T cells
BCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs
 Biological: BCMA-CS1 cCAR T cells
BCMA-CS1 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 28 days ]
  2. Type of dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
  3. Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 1 year ]
    Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies

  2. Progression-free survival (PFS) [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis based on the World Health Organization (WHO) 2008
  2. Patients have exhausted standard therapeutic options
  3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  4. Female must be not pregnant during the study

Exclusion Criteria:

  1. Prior solid organ transplantation
  2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156269


Contacts
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Contact: Kevin Pinz 6315386218 kevin.pinz@icellgene.com

Locations
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China
Chengdu Military General Hospital Recruiting
Chengdu, China
Contact: Fang Liu, MD, PhD         
Contact       lfyh2006@yahoo.com   
Peking University Shenzhen Hospital Recruiting
Shenzhen, China
Contact: Hongyu Zhang, MD, PhD         
Contact       HongyuZhang@pkuszh.com   
Sponsors and Collaborators
iCell Gene Therapeutics
Peking University Shenzhen Hospital
Chengdu Military General Hospital
iCAR Bio Therapeutics Ltd.
Investigators
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Principal Investigator: Hongyu Zhang, MD, PhD Peking University Shenzhen Hospital
Principal Investigator: Fang Liu, MD, PhD Chengdu Military General Hospital
More Information
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Responsible Party: iCell Gene Therapeutics
ClinicalTrials.gov Identifier: NCT04156269    
Other Study ID Numbers: ICG182-001
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iCell Gene Therapeutics:
BCMA
CS1
BCMA-CS1 cCAR T cells
CD269
SLAMF7
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases