BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

NCT03664661 | Unknown Phase 1 DMC

• 1 other identifier: HenanCH CAR 2-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Conditions

Relapsed/Refractory Myeloma

Outcome Measures

Primary Outcomes (1)

• occurrence of study related adverse events

  safety of CAR-T cells

  4 weeks

Secondary Outcomes (2)

• Treatment response rate

  3 months and 6 months

• copy number of CAR-T cells

  one year

Study Arms (1)

experimental group

EXPERIMENTAL

BCMA nanobody CAR-T cells

Drug: BCMA nanobody CAR-T cells

Interventions

BCMA nanobody CAR-T cells DRUG

step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.

experimental group

Eligibility Criteria

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

You may qualify if:

• and ≤70 years old and the expected lifetime \>3 months
• Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
• No effective treatment option available
• ECOG score 0-2
• Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
• smoothly peripheral superficial veins
• No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
• No history of other malignancies
• Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
• The patient himself agrees to participate in this clinical study and signed the "informed consent"

You may not qualify if:

• Severe infectious 4 weeks before enrollment
• Active hepatitis B or C viral hepatitis, HIV,
• Severe autoimmune disease or immunodeficiency disease
• Severe allergies
• Severe mental disorder
• Patients who used high-dose glucocorticoids within 1 week
• Participation in other clinical studies in the past 3 months or having been treated with other gene products

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• The Pregene (ShenZhen) Biotechnology Company, Ltd.: collaborator

Study Sites (1)

Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yongping Song, M.D

  Henan Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Yongping Song, M.D

CONTACT

+86-371-65587199; songyongping2018@126.com

Quanli Gao, M.D

CONTACT

+86-15038171966; gaoquanli2015@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: April 11, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 30, 2020
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

CN (1)