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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

PIC1 Injection Therapy for Relapsed/Refractory B-NHL

Clinical Study of PIC1 Injection for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

PIC1 Injection Therapy for Relapsed/Refractory B-NHL (NCT07456371) is a Phase 1 interventional studying Non-Hodgkin Lymphoma, sponsored by Chongqing Precision Biotech Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Non-Hodgkin Lymphoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - The patient (or their legally authorized representative) has voluntarily agreed to participate in this clinical trial and has signed the willing to sign a consent form Form (ICF), indicating full understanding of the study's objectives and procedures. - Aged 18 to 75 years, regardless of gender. - diagnosed by tissue sample (biopsy-confirmed) B-cell Non-Hodgkin Lymphoma (NHL) according to the WHO 2017 classification, including the following subtypes: 1. 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. 2. High-Grade B-Cell Lymphoma (HGBL): Including HGBL, NOS; and HGBL with MYC and BCL2 and/or BCL6 rearrangements. 3. Primary Mediastinal Large B-Cell Lymphoma. 4. T-cell/Histiocyte-rich Large B-Cell Lymphoma. 5. Transformed DLBCL: DLBCL transformed from prior lymphomas (e.g., Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Marginal Zone Lymphoma). 6. Follicular Lymphoma Grade 3b (FL3b). 7. 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: 1. Relapsed: Disease progression or recurrence after achieving a Complete Response (CR) to standard therapy. 2. 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. 3. No response, disease progression, or relapse after Autologous Stem Cell Transplantation (ASCT). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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: 1. 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. 2. High-Grade B-Cell Lymphoma (HGBL): Including HGBL, NOS; and HGBL with MYC and BCL2 and/or BCL6 rearrangements. 3. Primary Mediastinal Large B-Cell Lymphoma. 4. T-cell/Histiocyte-rich Large B-Cell Lymphoma. 5. Transformed DLBCL: DLBCL transformed from prior lymphomas (e.g., Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Marginal Zone Lymphoma). 6. Follicular Lymphoma Grade 3b (FL3b). 7. 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: 1. Relapsed: Disease progression or recurrence after achieving a Complete Response (CR) to standard therapy. 2. 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. 3. No response, disease progression, or relapse after Autologous Stem Cell Transplantation (ASCT). 4. Patients with transformed lymphoma who received chemotherapy prior to transformation and subsequently failed to achieve response, progressed, or relapsed after salvage therapy post-transformation. * CD19 positivity confirmed by immunohistochemistry (IHC) or flow cytometry. * ECOG performance status of 0 or 1. * Estimated life expectancy of ≥12 weeks. * At least one measurable lesion per the 2014 Lugano Criteria: 1. For nodal lesions: Longest diameter \>1.5 cm. 2. For extranodal lesions: Longest diameter \>1.0 cm. * Adequate major organ function defined as: 1. Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥40% by echocardiogram. 2. Renal function: Serum creatinine ≤2.0 × ULN or Creatinine Clearance ≥50 mL/min (calculated by Cockcroft-Gault formula). 3. Hepatic enzymes: ALT and AST ≤3.0 × ULN (or ≤5.0 × ULN for subjects with hepatic involvement). 4. Bilirubin: Total bilirubin ≤2.0 × ULN (or ≤3.0 × ULN for subjects with Gilbert's syndrome). 5. Oxygenation: Oxygen saturation (SpO2) ≥ 92% while breathing room air. 6. Hematology: Neutrophil Count ≥ 1.0 × 10\^9/L; Platelet count ≥ 75 × 10\^9/L; Hemoglobin ≥ 80 g/L. (For subjects with bone marrow involvement: Neutrophil ≥ 0.5 × 10\^9/L and Platelet count ≥ 50 × 10\^9/L.) * Women of childbearing potential must have a negative pregnancy test. All subjects must agree to use a highly effective method of contraception from the time of signing the ICF until 1 year after the infusion of the investigational product. Exclusion Criteria: * 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: 1. 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.) 2. Radiation therapy within 14 days before infusion. * Has any of the following cardiac conditions: 1. New York Heart Association (NYHA) Class III or IV congestive heart failure. 2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment. 3. Clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal reactions or dehydration). 4. 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. * Any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in this study.

Treatments Being Tested

BIOLOGICAL

PIC1 Injection

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07456371), the sponsor (Chongqing Precision Biotech Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07456371 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07456371?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07456371?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07456371. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07456371. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.