Trials / Not Yet Recruiting
Not Yet RecruitingNCT07168291
Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma
The Safety and Efficacy of Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Patients With Relapsed or Refractory B-cell Lymphoma: An Open-label, Single-arm Clinical Study
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-lable, single arm, non-randomized study to evaluate the primary safety and efficacy of the novel bispecific AbTCR (anti-CD19/CD22)-T cells in patients with relapsed or refractory B-cell lymphoma
Detailed description
The investigators previously developed CD19-targeted ET019003 T cells by fusing the Fab fragment with γ/δ TCR constant chain plus adding a co-stimulatory molecule. Among 12 treated patients enrolled in the phase I clinical trial (NCT03642496), 6 achieved complete remission and no serious adverse events were observed, demonstrating that ET019003 T cells are both safe and effective. However, its efficacy is limited in patients with loss of CD19 expression. To overcome tumor immune escape driven by antigen loss, investigators designed the novel AbTCR-T cells simultaneously targeting CD19 and CD22. This trial is conducted to explore the safety and efficacy of AbTCR (anti-CD19/CD22)-T cells in treating patients with refractory/relapsed aggressive lymphomas.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion | Cyclophosphamide 250 mg/m2 and fludarabine 30 mg/m2 IV infusion on day -5, -4, and -3. AbTCR (anti-CD19/CD22)-T cell IV infusion on day 0. |
Timeline
- Start date
- 2025-12-31
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2025-09-11
- Last updated
- 2025-09-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07168291. Inclusion in this directory is not an endorsement.