In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies

NCT07239323 | Recruiting Phase 1

• 1 other identifier: PBC027-1
• Study Type: interventional
• Target: 24
• 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 malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.

Conditions

B-Acute Lymphoblastic Leukemia; B Cell Non-Hodgkin's Lymphoma; Multiple Myeloma

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 (1)

• Objective Response Rate

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

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 old, gender unrestricted;
• Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;
• ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;
• Blood routine test results during the screening period meet the following criteria:
• ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL;
• Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor \[G-CSF\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL;
• Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula);
• Liver function during the screening period meets the following criteria:
• ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN;
• ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin can be relaxed to ≤ 1.5 × ULN);
• Cardiac function during the screening period meets the following criteria:
• ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan);
• ② No clinically significant pericardial effusion;
• ③ No clinically significant electrocardiogram (ECG) abnormalities;
• Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;

You may not qualify if:

• Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):
• ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;
• ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);
• History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;
• History of other malignant tumors (except for this disease), except for the following situations:
• ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;
• ② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;
• Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;
• Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;
• Clinically significant cardiac diseases:
• Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);
• Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) / coronary artery stent implantation within 6 months before signing the informed consent;
• Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;
• Other clinically significant diseases, including but not limited to:
• Primary immunodeficiency; ② Had a stroke or seizure within 6 months before 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

Burkitt Lymphoma; Lymphoma, B-Cell; Multiple Myeloma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Wang Sanbin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Sanbin, 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: November 16, 2025
• First Posted: November 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)