Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R POMES

NCT03879382 | Unknown Phase 1 DMC

• 1 other identifier: HRain-POMES01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory POMES Syndrome.

Conditions

POMES Syndrome; Relapsed and Refractory POMES Syndrome

Keywords

CD19/BCMA; Bispecific CAR-T Cell; POMES Syndrome; Relapsed and Refractory

Outcome Measures

Primary Outcomes (1)

• Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

  Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

  6 months

Secondary Outcomes (2)

• Overall complete remission rate defined by the standard response criteria for POMES Syndrome

  8 weeks

• Duration of CAR-positive T cells in circulation

  6 months

Study Arms (1)

anti-CD19/BCMA CAR-T cells

EXPERIMENTAL

Administration with anti-CD19/BCMA CAR-T cells in the relapsed and refractory POMES Syndrome patients

Biological: anti-CD19/BCMA CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

anti-CD19/BCMA CAR-T cells BIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

anti-CD19/BCMA CAR-T cells

Fludarabine DRUG

30mg/m2/d

anti-CD19/BCMA CAR-T cells

Cyclophosphamide DRUG

300mg/m2/d

anti-CD19/BCMA CAR-T cells

Eligibility Criteria

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

You may qualify if:

• Expected survival \> 12 weeks;
• Diagnosis of POMES Syndrome;
• The criteria for relapsed and refractory POMES Syndrome: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including Alkylating agent and other protein inhibitors (eg: Bortezomib), and have disease progression in the past 60 days;
• At least 90 days after stem cell transplantation;
• Creatinine≤2.0 mg/dl;
• Bilirubin≤2.0 mg/dl;
• The ALT/AST value is lower than 2.5-fold of normal value;
• Accessible to intravenous injection, and no white blood cell collection contraindications;
• Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom;
• mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion;
• Able to understand and sign the Informed Consent Document.

You may not qualify if:

• In the first 5 years before screening, there are malignant tumors other than POMES Syndrome, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery，and catheter carcinoma in situ after radical surgery;
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency Viral (HIV) antibody positive; Positive syphilis test;
• Any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (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 requiring medication;
• Any other diseases could affect the outcome of this trial;
• Any affairs could affect the safety of the subjects or outcome of this trial;
• Pregnant or lactating women, or planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
• Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
• Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
• Received CAR-T treatment or other gene therapies before enrollment;
• Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
• Subject suffering disease affects the understanding of informed consent or comply with study protocol;
• The investigators consider other conditions unsuitable for enrollment.

Sponsors & Collaborators

• Hrain Biotechnology Co., Ltd.: lead
• Shanghai Changzheng Hospital: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

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: March 15, 2019
• First Posted: March 18, 2019
• Study Start: February 27, 2019
• Primary Completion: August 30, 2020
• Study Completion: May 30, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)