Clinical trial · Interventional
A Phase 1/2 Study of T-cell Expressing an Anti-CD22 Chimeric-Antigen Receptor (SHB-04-CD22) in Patients With CD22-expressing B-cell Malignancies
NCT07135466CI-TRIAL-00101038recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I/II trial of T-cell expressing an anti-CD22 Chimeric-Antigen-Receptor (CAR) in patients with CD22 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD22 CAR-T cells | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm, open label, dose escalation: Anti CD22 CAR-T (SHB-04-CD22)
- description
- Phase 1 of this study includes a dose escalation plan of anti CD22 CAR-T (SHB-04-CD22). Treatment will start at dose level 1. According to safety assessments, dose will increase to next dose level. Dose level 1: 3x10\^5 CAR+ T cells per kilogram Dose level 2: 1x10\^6 CAR+ T cells per kilogram Dose level 3: 3x10\^6 CAR+ T cells per kilogram Phase 2 of this study will be a dose expansion phase of the dose recommended based on safety and expected efficacy.
- interventionNames
- Other: CD22 CAR-T cells
Primary outcomes (3)
- measure
- Safety Evaluation: Treatment Related Toxicities
- timeFrame
- From enrollment to 3 months post treatment.
- description
- An evaluation of safety of the use of autologous anti-CD22 CAR T cells (SHB-04-CD22) manufactured at the Sheba Medical Center, in patients with relapsed/refractory B-cell malignancies. Safety will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have a CD22-expressing hematologic malignancy, relapsed or refractory after receiving at least 2 lines of standard therapy including CD19-directed therapy (For CD19 positive disease): * Relapse following standard relapse protocol (2nd relapse), including CD19 CART. * Primary refractory, i.e. failed to achieve morphologic remission after 2 lines of induction chemotherapy. * Age 1-80 years * CD22 expression shown by flow cytometry on at least 70% of leukemic blasts / lymphoma cells * Adequate CD3 count (above 120 CD3+ cells per microliter blood) * Clinical performance status: Patients \> 10 years of age: Karnofsky ≥ 50%; Patients ≤ 10 years of age: Lansky scale ≥ 50%. Exception for neurologic symptoms (e.g. paralysis) that are explained by the malignancy. * Females of child-bearing potential must have a negative pregnancy test * Cardiac function: LV ejection fraction \>45% or shortening fraction \>28% * At least 60 days after autologous or allogeneic BMT * At least 30 days after prior CAR therapy in absence of response
References
Publications (0)
Data not yet available
No reference posted for this study.