A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma

NCT03767751 | Unknown Phase 1

• 1 other identifier: CHN-PLAGH-BT-037
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability

  24weeks

• MTD of dual specificity CD38 and BCMA CAR-T cells

  The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells

  4 weeks

• Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes

  24 weeks

Secondary Outcomes (3)

• Six-month Objective response rate of complete remission and partial remission

  24 weeks

• Six-month Overall survival

  24 weeks

• Six-month Progression free survival

  24 weeks

Interventions

Dual Specificity CD38 and bcma CAR-T Cells BIOLOGICAL

1\) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant
• Years to 70 Years (Child, Adult, Senior)
• Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Adequate organ function

You may not qualify if:

• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
• Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
• Richter's syndrome
• Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
• Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
• Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
• Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
• Patient has an investigational medicinal product within the last 30 days prior to screening
• Previous treatment with investigational gene or cell therapy medicine products
• Pregnant or nursing women

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

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

Central Study Contacts

YaJing Zhang

CONTACT

86-10-55499341; plagh@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Molecular & Immunological Department,Biotherapeutic Department

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: December 5, 2018
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

CN (1)