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

NCT07135466 | Recruiting Phase 1

• 2 other identifiers: SHB-04-CD222289-25-SMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

B Cell Malignancies

Keywords

ALL; NHL; DLBCL; CAR-T; CD22; Chimeric Antigen Receptor; Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (3)

• Safety Evaluation: Treatment Related Toxicities

  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.

  From enrollment to 3 months post treatment.

• Efficacy Evaluation

  An evaluation of the feasibility and efficacy of administering anti-CD22-CAR T cells (SHB-04-CD22) in patients with B-cell malignancies at the Sheba Medical Center. Efficacy will be determined by an evaluation of disease response in participants post treatment. Disease response will be assessed by blasts percentage in bone marrow for ALL patients and by PET-CT scan based on the Lugano classification for NHL patients.

  1 month to 1 year post treatment.

• Minimal toxic dose evaluation

  An evaluation of the minimal toxic dose of CD22 CAR-T cells (SHB-04-CD22). This will be determined by evaluation of participants with treatment-related adverse events, as assessed by CTCAE 5.0, and according to different dose levels administered.

  From first dose to end 3 months post treatment.

Study Arms (1)

Single arm, open label, dose escalation: Anti CD22 CAR-T (SHB-04-CD22)

EXPERIMENTAL

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.

Other: CD22 CAR-T cells

Interventions

CD22 CAR-T cells OTHER

CD22 CAR-T cells

Single arm, open label, dose escalation: Anti CD22 CAR-T (SHB-04-CD22)

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, G, Israel

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Prof. Elad Jacoby, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivan Yakobi

CONTACT

972 03 5309046; sivan.yakobi@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Hematology and Oncology

Model Details: Single arm, open label, non-randomized trial

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 22, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)