Dual-target CAR-T Cells (C-4-29) in the Treatment of Relapsed/Refractory Multiple Myeloma

NCT04861480 | Unknown Phase 1

• 1 other identifier: PB04
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I clinical study to evaluate the safety and tolerability of C-4-29 in patients with relapsed or refractory multiple myeloma, and to obtain the maximum tolerated dose of C-4-29 and phase II Recommended dose.

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Keywords

Multiple Myeloma; CAR-T

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse events after C-4-29 infusion [Safety and Tolerability]

  Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  28 days

• Obtain the maximum tolerated dose of C-4-29 cells[Safety and Tolerability]

  Dose-limiting toxicity after cell infusion

  28 days

Secondary Outcomes (7)

• Objective response rate after C-4-29 infusion [Effectiveness]

  3 months

• AUCS of C-4-29 cells [Cell dynamics]

  3 months

• CMAX of C-4-29 cells [Cell dynamics]

  3 months

• TMAX of C-4-29 cells [Cell dynamics]

  3 months

• Peripheral blood M protein contents after C-4-29 infusion [Cell dynamics]

  3 months

Other Outcomes (3)

• Overall survival after C-4-29 infusion

  2 years

• Progression-free survival after C-4-29 infusion

  2 years

• Duration of relief after C-4-29 infusion

  2 years

Study Arms (1)

C-4-29 cells

EXPERIMENTAL

Infusion of C-4-29 cells by dose-escalating

Biological: C-4-29 Cells

Interventions

C-4-29 Cells BIOLOGICAL

Drug: C-4-29 Cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

C-4-29 cells

Eligibility Criteria

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

You may qualify if:

• ≥18 years old, no gender limit;
• Diagnosed with multiple myeloma according to the IMWG diagnostic criteria.
• Received third-line and above regular treatments (including proteasome inhibitors or immunomodulators) that are ineffective or intolerable;
• The disease is measurable during screening:
• Serum M protein level ≥0.5g/dL, or urine M protein level ≥200mg/24h;
• Or light chain type MM with undetectable serum or urine disease: serum immunoglobulin free light chain ≥10mg/dL and serum immunoglobulin κ/γ free light chain ratio is abnormal;
• Or evaluable extramedullary lesions with the largest transverse diameter ≥ 1 cm.
• ECOG 0～2 points;
• The expected survival time is more than 12 weeks;
• No serious mental disorders;
• The function of important organs is basically normal:
• Heart function: echocardiography indicates that the cardiac ejection fraction is ≥50%, and the electrocardiogram has no obvious abnormalities;
• Renal function: serum creatinine≤2.0×ULN;
• Liver function: ALT and AST ≤3×ULN;
• Total bilirubin and alkaline phosphatase≤2×ULN (Gilbert syndrome≤3.0×ULN);

You may not qualify if:

• Have received CAR-T therapy or other genetically modified cell therapy;
• With central nervous system disease at the time of screening ;
• Participated in other clinical studies within 1 month before screening;
• Have received a live attenuated vaccine within 4 weeks before screening;
• Have received the following anti-tumor treatments before apheresis: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
• Within 7 days before apheresis, there are active infections or uncontrollable infections that require systemic treatment (except CTCAE grade 1 genitourinary system infection and upper respiratory tract infection);
• Suffered from plasma cell leukemia at the time of screening ;
• Suffered from other malignant tumors other than multiple myeloma within 3 years before screening, except for the following cases: malignant tumors that have received radical treatment, and there is no known active disease for ≥3 years before enrollment; or fully treated non-melanoma skin cancer with no evidence of disease;
• Except for hair loss or peripheral neuropathy, the toxicity of previous anti-tumor treatments has not improved to the baseline level or ≤grade 1;
• Subjects who have received systemic steroid treatment within 7 days before apheresis or who have been determined by the investigator to require long-term systemic steroid treatment during treatment (except for inhaled or topical use);
• Suffered from any of the following heart diseases:
• NYHA stage III or IV congestive heart failure;
• Myocardial infarction or CABG occurred ≤6 months before enrollment;
• Clinically significant ventricular arrhythmia, or history of unexplained syncope (except for cases caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

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

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: April 6, 2021
• First Posted: April 27, 2021
• Study Start: June 16, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 18, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)