Treatment of Chemotherapy Refractory Multiple Myeloma by CART-138

NCT01886976 | Unknown Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.

Conditions

Multiple Myeloma

Keywords

multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events

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

  Until week 24

Secondary Outcomes (1)

• Anti-myeloma responses to CART-138 cell infusions

  up to 24 weeks

Other Outcomes (1)

• in vivo existence of CART-138

  1 year

Study Arms (1)

anti-CD138 CAR T cells

EXPERIMENTAL

Patients receive anti-CD138-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.

Biological: CART-138 cells

Interventions

CART-138 cells BIOLOGICAL

Also known as: chimeric antigen receptor T cells with specificity for CD138 genetically modified lymphocyte therapy

anti-CD138 CAR T cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 therapy
• Adequate venous access for apheresis, and no other contraindications for leukapheresis
• Voluntary informed consent is given

You may not qualify if:

• 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.
• 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 costimulation.
• Any uncontrolled active medical disorder that would preclude participation as outlined.
• HIV infection.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Immunotherapy, Adoptive; Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (1)