BCMA and CD19 Targeted Fast Dual CART for Chromosomal Abnomalities High-risk BCMA+ Multiple Myeloma

NCT04617704 | Unknown Early Phase 1

• 1 other identifier: GBF003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open label, multi-center prospective study to explory the safety and efficacy of GC012F CAR-T cells in patient diagnosed with high-risk chromosomal abnormalities BCMA+ multiple myeloma(MM).

Conditions

Multiple Myeloma

Keywords

high-risk; Fast; Chimeric Antigen Receptor T; BCMA; CD19; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events after GC012F injection

  Minimum 2 years after GC012F infusion

Secondary Outcomes (10)

• Percentage of MRD negative patients after GC012F infusion

  Minimum 2 years after GC012F infusion

• ORR(PR, VGPR, CR and sCR) of patients after GC012F treatment

  Minimum 2 years after GC012F infusion(Day0)

• Progression free survival after GC012F treatment

  Minimum 2 years after GC012F infusion(Day0)

• Duration of response of subjects after GC012F treatment

  Minimum 2 years after GC012F infusion(Day0)

• Overall survivalof subjects after GC012F treatment

  Minimum 2 years after GC012F infusion(Day0)

Study Arms (1)

Experimental:GC012F treatment

EXPERIMENTAL

BCMA+ cytogenetic high-risk multiple myeloma patients be treated with a single dose of GC012F cells. Total dose of (1-5)\*10\^5/kg cells will be administered at Day 0

Biological: GC012F injection

Interventions

GC012F injection BIOLOGICAL

GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.

Experimental:GC012F treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosis of active MM as defined by any of following: a) serum M protein more than or equal to 10g/dL; b) urine M protein more than or equal to 200mg/24 h; c) involved serum free light chain more than or equal to 100mg/dL with abnormal serum kappa lambda ratio;
• Patients with clear BCMA expression(percent of BCMA positive plasma cells more than or equal to 20%) detected by flow cytometry;
• High-risk chromosomal abnormal defined as presence of del17p, and/or t(4;14) and/or t(14;16);
• Estimated life expectancy more than or equal to 3 months;
• Absolute neutrophil count more than or equal to 1\*10\^9/L;
• Platelet count more than or equal to 25\*10\^9/L;
• Absolute lymphocyte count more than or equal to 1\*10\^8/L;
• Liver, kidney and cardiopulmonary functions meet the following requirements: a) Total bilirubin less than or equal to 2\*ULN(except for Gilbert Syndrome); ALT and AST less than or equal to 2.5\*ULN, maintenance of kidney function not depend on dialysis; c)Corrected serum calcium less than or equal to 12.5 mg/dL or free ion calcium less than or equal to 6.5mg/dL(1.6mmol/L);
• Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
• Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T infusion;
• subjects must have signed writtern informed consent.

You may not qualify if:

• Accompanied by other unctrolled maligancies. Two exceptions to this criteria: Recepted radical therapy carcinoma without activity within 3 years before screening; fully treated skin non-melanoma;
• Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best intreat(eg., harm to health), or any situation that may prevent, limit or confuse the assessment;
• Convulsion or stoke within past 6 months;
• Any instability or systemic disease within 6 months prior to screening, including but not limited to congestive heart failure(New York heart association classification ≥ III)， unstable angina, cerebrovascular accident, or transient cerebral ischemic, myocardial infarction, LEVF\<50%(assessed by an echocardiogram or multi-door circuit scan);
• Patients have central nervous system(CNS) metastases or CNS involvement(including cranial neuropathies or mass lesions and leptomeningeal disease);
• Subjects with positive HBsAg or HBcAb positive and peripheal blood HBV-DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; syphilis primary screening antibody positive;
• Presence or suspicious of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
• Activity of autoimmune disease (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), orhistory of autoimmune disease within the last 3 years;
• Clinical evidence of dementia or changes of mental state;
• Exist of pulmonary fibrosis;
• Allergy subjects or history of severe hypersensitivity;
• Oxgen inhalation requirement to maintain adequate oxygen saturation;
• Surgery (except for local anesthesia surgery) plan 2 weeks before apheresis, during or 2 weeks after CAR-T infusion;
• Patients who are accounted to be not appropriate for this investigator.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Multiple Myeloma; Fasting

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; Feeding Behavior; Behavior

Central Study Contacts

Weijun Fu

CONTACT

+8613816052522; fuweijun2010@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: November 5, 2020
• Study Start: December 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2020-10

Locations

CN (1)