KSV01 injection for relapsed or refractory diffuse large B‑cell lymphoma
A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
This trial will test a new injectable treatment called KSV01 in adults with relapsed or refractory diffuse large B‑cell lymphoma to see if it is safe and can help control the cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | TCRx Therapeutics Co.Ltd Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07260812 on ClinicalTrials.gov |
What this trial studies
This is a single‑center, single‑arm, open‑label Phase 1 dose‑escalation trial of KSV01 injection in adults with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). Eligible patients must have CD19‑positive disease, PET‑positive target lesions (Deauville ≥4), adequate organ function, and ECOG performance status ≤1. The study will escalate doses to define safety, tolerability, and preliminary signs of anti‑tumor activity. Participants are treated and followed at Tongji Hospital with predefined safety and response assessments.
Who should consider this trial
Good fit: Adults 18–80 years with relapsed or refractory DLBCL after at least one prior systemic therapy, confirmed CD19 positivity, PET‑positive lesions (Deauville ≥4), ECOG ≤1, and adequate organ function are the ideal candidates.
Not a fit: Patients who are CD19‑negative, have poor performance status, major organ dysfunction, life expectancy ≤3 months, are pregnant, or cannot comply with dosing and follow‑up are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, KSV01 could become a new treatment option that helps control disease in some patients with relapsed or refractory CD19‑positive DLBCL.
How similar studies have performed: Other CD19‑targeted approaches such as CAR‑T cell therapies and bispecific antibodies have shown meaningful benefit in relapsed/refractory DLBCL, but KSV01 is an investigational injectable therapy and remains unproven in early‑phase testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Patients or their legal guardians voluntarily participate in the study and provide written informed consent.
2. Aged 18 to 80 years (inclusive), male or female.
3. ECOG performance status score of ≤ 1.
4. Life expectancy \> 3 months.
5. KPS score ≥ 70.
6. Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.
7. CD19 positivity confirmed by flow cytometry and/or histopathology.
8. According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \[5-PS\] ≥ 4).
9. Adequate organ function.
10. Female patients of childbearing potential must have a negative urine/blood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.
Exclusion Criteria:
1. History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.
2. Uncontrolled infectious disease within 4 weeks prior to enrollment.
3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. HIV infection.
5. Positive for Treponema pallidum(syphilis).
6. Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
7. History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).
8. Participation in any other clinical trial within 4 weeks prior to enrollment.
9. History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.
10. Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.
11. History of severe cardiovascular conditions within the past 6 months.
12. Presence of psychiatric illness.
13. History of drug abuse or addiction.
14. Use of the following medications or therapies:
1. Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).
2. Chemotherapy.
3. GvHD Therapy.
4. Allogeneic hematopoietic stem cell transplantation.
5. Gene therapy.
15. Women who are breastfeeding.
16. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.