In Vivo PICX CAR-T Therapy for R/R Multiple Myeloma

NCT07715630 | Recruiting Phase 1

• 1 other identifier: PBC027-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an investigator-initiated, single-center, single-arm clinical study with a target population of patients with relapsed or refractory multiple myeloma. It is an early exploratory clinical study evaluating the safety, tolerability, and preliminary efficacy of PICX Injection, an in vivo prepared CAR-T cell therapy, in the treatment of relapsed or refractory multiple myeloma.

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Keywords

in Vivo; CAR-T; malignant hematological tumors

Outcome Measures

Primary Outcomes (2)

• Maximal Tolerated Dose (MTD)

  MTD will be determined based on Dose-Limiting Toxicity (DLTs) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

• Incidence of Adverse Events (AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Up to 28 days after infusion

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Day 28#Month 2#Month 3#Month 6#Month 12#Month 18#Month 24

• Minimal Residual Disease (MRD) Negative Rate

  Month 3#Month 6#Month 12#Month 18#Month 24

• Time to Response (TTR)

  Up to 24 months

• Duration of Response (DOR)

  up to 24 months

• Progression-Free Survival (PFS)

  up to 24 months

Study Arms (1)

Invivo CAR-T

EXPERIMENTAL

Biological: Invivo CAR-T

Interventions

Invivo CAR-T BIOLOGICAL

Patients were enrolled and given a single dose of CAR-T injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.

Invivo CAR-T

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, male or female;
• Confirmed diagnosis of multiple myeloma meeting at least one of the following criteria:
• Disease progression after at least 2 prior standard treatment regimens; or poor response to primary therapeutic agents (e.g., immunomodulatory agents, proteasome inhibitors)
• Disease progression within 18 months after first-line therapy
• Presence of features associated with high risk of disease relapse or progression (e.g., high-risk cytogenetic abnormalities);
• At least one measurable disease indicator:
• Serum M-protein ≥ 0.5 g/dL
• Urine M-protein ≥ 200 mg/24 hours
• Involved serum free light chain (sFLC) ≥ 10 mg/dL with an abnormal serum free light chain κ/λ ratio
• No evidence of extramedullary plasmacytoma (soft tissue plasmacytoma);
• ECOG performance status score 0-2;
• Expected survival period ≥ 3 months;
• Adequate bone marrow function within 1 month prior to screening:
• Hemoglobin ≥ 60 g/L;
• Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L;

You may not qualify if:

• Prior treatment with CAR-T therapy or other gene-modified cell therapy before screening;
• Presence of active central nervous system (CNS) involvement at screening (including brain parenchymal, meningeal, or spinal meningeal involvement, or positive cerebrospinal fluid for tumor cells), or other CNS diseases;
• Received the following anti-tumor therapies prior to PICX Injection infusion:
• Chemotherapy, combination therapy with proteasome inhibitors and immunomodulatory agents, or other systemic anti-tumor drug therapy within 14 days or at least 5 half-lives before infusion (excluding intrathecal chemotherapy, which must be discontinued at least 1 week prior to infusion);
• Radiotherapy to non-hematopoietic sites within 7 days, or to hematopoietic sites within 14 days before infusion;
• BCMA-targeting antibody-based therapy within 3 months before infusion;
• Active or uncontrolled infection requiring systemic treatment at screening (including bacterial, viral, fungal, or other infections);
• Presence of any of the following cardiac conditions:
• New York Heart Association (NYHA) Class III or IV congestive heart failure;
• Myocardial infarction, or coronary artery bypass grafting (CABG), or coronary stent placement within 6 months prior to screening;
• Clinically significant ventricular arrhythmia, or history of syncope of unknown cause (excluding vasovagal or dehydration-related);
• History of severe non-ischemic cardiomyopathy;
• Presence of other clinically significant diseases or conditions, including:
• Primary immunodeficiency disease;
• Cerebrovascular accident or seizure within 6 months prior to screening;

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Sanbin Wang, PhD

CONTACT

+86 13187424131; sanbin1011@163.com

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: July 14, 2026
• First Posted: July 20, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)