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NCT07369492
A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Phase 1 trial testing BAFF-R CAR-T cells in B-cell Lymphoma in 30 participants. Currently enrolling.
1 January 2027
Quick facts
| Lead sponsor | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2026 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 January 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- BAFF-R CAR-T cells — full drug profile →
Conditions studied
- B-cell Lymphoma — all drugs for B-cell Lymphoma →
Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of dose-limiting toxicity (DLT)
Time frame: 1 month after injection
Dose-limiting toxicity for each subject -
AE/SAE
Time frame: 1 month, 3 months, 6 months, 12 months after injection
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
Sponsor's own description
The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07369492
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for B-cell Lymphoma
Currently open trials in the same condition.
- NCT07211048 — Anti CD19 Gene Therapy for B-cell Lymphoma · NA · recruiting
- NCT06758713 — Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies · Phase 1 · recruiting
- NCT06820268 — A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies · Phase 1 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06744075 — Study of the Clearance of Minimal Residual Disease Measured at the End of First-line Treatment in Patients With Lymphoma · NA · active not recruiting
Other Jiangsu Topcel-KH Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07452822 — Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in · Phase 1, PHASE2 · not yet recruiting
- NCT06925594 — Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease · Phase 3 · recruiting
- NCT05677672 — The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Com · Phase 1, PHASE2 · unknown
- NCT05626023 — A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07369492 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07369492.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing