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Non-Hodgkin LymphomaPhase 1NCT07456371

PIC1 Injection Therapy for Relapsed/Refractory B-NHL

A Phase 1 study testing PIC1 Injection in people with Non-Hodgkin Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
PIC1 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Mar 2026to Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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:
  • For nodal lesions: Longest diameter >1.5 cm.
  • For extranodal lesions: Longest diameter >1.0 cm.
  • Adequate major organ function defined as:
  • Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥40% by echocardiogram.
  • Renal function: Serum creatinine ≤2.0 × ULN or Creatinine Clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).
  • Hepatic enzymes: ALT and AST ≤3.0 × ULN (or ≤5.0 × ULN for subjects with hepatic involvement).
  • Bilirubin: Total bilirubin ≤2.0 × ULN (or ≤3.0 × ULN for subjects with Gilbert's syndrome).
  • Oxygenation: Oxygen saturation (SpO2) ≥ 92% while breathing room air.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jia Wei contact

+86 13986102084

jiawei@tjh.tjmu.edu.cn

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430030

    Jia Wei, +86 13986102084, jiawei@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo generated Chimeric Antigen Receptor T-cell (CAR-T) therapy in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma. Upon enrollment, subjects will receive an intravenous infusion of PIC1 injection designed for in vivo CAR-T generation. Following infusion, subjects will be hospitalized for observation and evaluated for safety and efficacy. Subjects will be followed for up to 2 years to assess long-term disease control.

Being tested
PIC1 Injection
Keywords
CAR-T, CD19, in vivo
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PIC1 InjectionBiological

    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.

Study groups in NCT07456371
Study groupRoleWhat they receive
PIC1 InjectionExperimentalNot described
Receives: Biological: PIC1 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs) after infusion

    Types, frequency and severity of adverse events.

    Measured: 1 month

Secondary outcomes (10)

  1. Overall Response Rate (ORR)

    The proportion of patients achieving a Complete Response (CR) and Partial Response (PR) post-treatment, as assessed per the Lugano 2014 criteria.

    Measured: 3 months

  2. Best Overall Response (BOR)

    The proportion of patients achieving a Complete Response (CR) or Partial Response (PR) post-treatment.

    Measured: 3 months

  3. Duration of Response (DOR)

    The time interval from the first documentation of CR or PR to the first documentation of disease progression (PD) or death from any cause, whichever occurs first. This metric applies only to subjects who achieve a confirmed response.

    Measured: 3 months

  4. Progression-Free Survival (PFS)

    The time from the initiation of PIC1 treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.

    Measured: 3 months

  5. Overall Survival (OS)

    The time from the initiation of PIC1 treatment to death from any cause.

    Measured: 3 months

  6. The maximum concentration (Cmax)

    The maximum concentration (Cmax) of CAR-T cells in peripheral blood resulting from in vivo expansion after infusion.

    Measured: 1 month

  7. The time to maximum concentration (Tmax)

    The time to reach the maximum concentration (Cmax) of CAR-T cells in peripheral blood resulting from in vivo expansion after infusion.

    Measured: 1 month

  8. AUC 28d

    The area under the concentration-time curve of CAR-T cells in peripheral blood over the 28-day period (AUC 28d) after infusion.

    Measured: 1 month

  9. Serum cytokine levels

    Serum cytokine levels (such as IL-6, IL-10, TNF-α, IFN-γ) at various time points after infusion.

    Measured: 1 month

  10. Peripheral blood lymphocyte subsets

    Peripheral blood lymphocyte subsets (T, B, and NK cell proportions or counts) at various time points after infusion.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07456371
Sponsor's protocol ID
PBC108
Status last verified
Mar 2026
First submitted
2 Mar 2026
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PIC1 Injection in people with Non-Hodgkin Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jia Wei (+86 13986102084, jiawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) after infusion (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07456371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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