PIC1 Injection Therapy for Relapsed/Refractory B-NHL
ConditionNon-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChongqing Precision Biotech Co., Ltd
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
Received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy or any other gene-modified cell therapy before screening.
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.
New York Heart Association (NYHA) Class III or IV congestive heart failure.
Trial design
Design model
Single group
Treatments tested in this trial
PIC1 Injection
Biological/VaccineThree 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: PIC1 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (AEs) after infusion
Types, frequency and severity of adverse events.
Time frame
1 monthSecondary outcomes
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.
Time frame
3 months2
Best Overall Response (BOR)
The proportion of patients achieving a Complete Response (CR) or Partial Response (PR) post-treatment.
Time frame
3 months3
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.
Time frame
3 months4
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.
Time frame
3 monthsOther outcomes
1
Viral vector sequences
Viral vector sequences will be detected in blood, saliva, urine, and fecal samples until two consecutive negative results are obtained, to evaluate the potential risk of environmental shedding of the viral vector.
Time frame
1 monthSponsors and contacts
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Source ClinicalTrials.gov