PIC1 Injection Therapy for Relapsed/Refractory B-NHL

NCT07456371 | Recruiting Phase 1

• 1 other identifier: PBC108
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed/refractory B-cell Non-Hodgkin Lymphoma.

Conditions

Non-Hodgkin Lymphoma

Keywords

CAR-T; CD19; in vivo

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) after infusion

  Types, frequency and severity of adverse events.

  1 month

Secondary Outcomes (10)

• Overall Response Rate (ORR)

  3 months

• Best Overall Response (BOR)

  3 months

• Duration of Response (DOR)

  3 months

• Progression-Free Survival (PFS)

  3 months

• Overall Survival (OS)

  3 months

Other Outcomes (1)

• Viral vector sequences

  1 month

Study Arms (1)

PIC1 Injection

EXPERIMENTAL

Biological: PIC1 Injection

Interventions

PIC1 Injection BIOLOGICAL

Three dose groups (1.0×10\^9 TU, 2.0×10\^9 TU, 4.0×10\^9 TU) were set up, starting from the low dose group climbing to explore the safe and effective dose.

PIC1 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient (or their legally authorized representative) has voluntarily agreed to participate in this clinical trial and has signed the Informed Consent Form (ICF), indicating full understanding of the study's objectives and procedures.
• Aged 18 to 75 years, regardless of gender.
• Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma (NHL) according to the WHO 2017 classification, including the following subtypes:
• Diffuse Large B-Cell Lymphoma (DLBCL): Including DLBCL, not otherwise specified (DLBCL, NOS); DLBCL associated with chronic inflammation; Primary Cutaneous DLBCL, leg type; and EBV-positive DLBCL, NOS.
• High-Grade B-Cell Lymphoma (HGBL): Including HGBL, NOS; and HGBL with MYC and BCL2 and/or BCL6 rearrangements.
• Primary Mediastinal Large B-Cell Lymphoma.
• T-cell/Histiocyte-rich Large B-Cell Lymphoma.
• Transformed DLBCL: DLBCL transformed from prior lymphomas (e.g., Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Marginal Zone Lymphoma).
• Follicular Lymphoma Grade 3b (FL3b).
• Mantle Cell Lymphoma.
• Patients must have received adequate prior therapy including an anti-CD20 monoclonal antibody and an anthracycline, unless contraindicated or intolerant (i.e., CD20-negative status, intolerance to anti-CD20 mAb, or contraindication to anthracyclines). Patients must meet the definition of Relapsed or Refractory (R/R) disease:
• Relapsed: Disease progression or recurrence after achieving a Complete Response (CR) to standard therapy.
• Refractory: Best response of Stable Disease (SD) after at least 4 cycles of first-line therapy or at least 2 cycles of last-line therapy (≥2nd line), with SD duration ≤6 months after the last dose; or best response of Progressive Disease (PD) to the last treatment.
• No response, disease progression, or relapse after Autologous Stem Cell Transplantation (ASCT).
• Patients with transformed lymphoma who received chemotherapy prior to transformation and subsequently failed to achieve response, progressed, or relapsed after salvage therapy post-transformation.

You may not qualify if:

• Received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy or any other gene-modified cell therapy before screening.
• Received any of the following anti-tumor therapies prior to PIC1 infusion:
• medications (e.g., chemotherapy, targeted therapy) within 14 days or 5 half-lives (whichever is longer) before infusion. (excluding lymphodepleting chemotherapy and intrathecal chemotherapy for CNS lymphoma. And intrathecal chemotherapy must be discontinued at least 1 week prior to PIC1 infusion.)
• Radiation therapy within 14 days before infusion.
• Has 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) within 6 months prior to enrollment.
• Clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal reactions or dehydration).
• History of severe non-ischemic cardiomyopathy.
• Has an active or uncontrolled infection requiring systemic treatment within 1 week prior to screening.
• Has Grade 2-4 acute GVHD or moderate-to-severe chronic GVHD within 4 weeks prior to screening.
• Has experienced a cerebrovascular accident or seizure within 6 months prior to screening.
• Has experienced a deep vein thrombosis or arterial embolism event within 6 months prior to screening.
• Has a history of other malignancies except for: tumors with no evidence of active disease where treatment was completed \>2 years ago; adequately treated carcinoma in situ of the cervix; basal cell or squamous cell skin cancer; radical prostatectomy; radical ductal carcinoma in situ.
• Received a live attenuated vaccine within 4 weeks prior to screening.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jia Wei

CONTACT

+86 13986102084; jiawei@tjh.tjmu.edu.cn

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: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CN (1)