Know Cancer

forgot password

Clinical Study of Chimeric CD(Cluster of Differentiation)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas

Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Relapsed and/or Chemotherapy Resistant Multiple Myeloma

Thank you

Trial Information

Clinical Study of Chimeric CD(Cluster of Differentiation)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas


I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD138 vector (referred to as CART-138 cells).

II. Determine duration of in vivo survival of CART-138 cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood and bone marrow will be used to detect
and quantify survival of CART-138 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over


I. For patients with detectable disease, measure anti-myeloma response due to CART-138 cell

II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as
measured by the relative engraftment levels of CART-138 TCR zeta:CD137 and TCR zeta cells
over time.

III. Estimate relative trafficking of CART-138 cells in bone marrow.

IV. For patients with stored or accessible myeloma cells, determine myeloma cell killing by
CART-138 cells in vitro.

V. Determine if cellular or humoral host immunity develops against the murine anti-CD138,
and assess correlation with loss of detectable CART-138 (loss of engraftment).

VI. Determine the relative subsets of CART-138 T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-CD138-CAR (coupled with CD137 and CD3 zeta signalling
domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 13 years.

Inclusion Criteria:

- Male and female subjects with CD138 positive multiple myeloma in patients with no
available curative treatment options (such as autologous or allogeneic SCT) who have
limited prognosis (several months to < 2 year survival) with currently available
therapies will be enrolled.

- CD138 positive multiple myeloma CR can not be achieved after at least 4 prior
combination chemotherapy regimens.

- MM in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of
age, comorbid disease, or lack of available family member or unrelated donor.

- Less than 1 year between last chemotherapy and progression (i.e. most recent
progression free interval < 1 year).

- Relapsed after prior autologous or allogenic SCT. MM patients with relapsed or
residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.

- Residual disease after primary therapy and not eligible for autologous SCT

- Expected survival > 12 weeks

- Creatinine < 2.5 mg/dl

- ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal

- Bilirubin < 2.0 mg/dl

- Any relapse after prior SCT will make patient eligible regardless of other prior

- Adequate venous access for apheresis, and no other contraindications for

- Voluntary informed consent is given

Exclusion Criteria:

- Pregnant or lactating women

- The safety of this therapy on unborn children is not known. Female study participants
of reproductive potential must have a negative serum or urine pregnancy test
performed within 48 hours before infusion.

- Uncontrolled active infection.

- Active hepatitis B or hepatitis C infection.

- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not

- Previously treatment with any gene therapy products

- Feasibility assessment during screening demonstrates < 30% transduction of target
lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137

- Any uncontrolled active medical disorder that would preclude participation as

- HIV infection.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of study related adverse events

Outcome Description:

defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Outcome Time Frame:

Until week 24

Safety Issue:



China: Ethics Committee

Study ID:




Start Date:

June 2013

Completion Date:

June 2016

Related Keywords:

  • Relapsed and/or Chemotherapy Resistant Multiple Myeloma
  • multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell