Actively Recruiting

Phase 1
Phase 2
Age: 1Year - 80Years
All Genders
NCT07135466

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

Led by Sheba Medical Center · Updated on 2026-01-16

50

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of CD22-expressing blood cancer that has relapsed or is refractory after at least 2 lines of standard therapy including CD19-directed treatment
  • Disease relapse after standard relapse protocol including CD19 CAR T-cell therapy
  • Primary refractory disease after 2 induction chemotherapy lines
  • Age between 1 and 80 years
  • CD22 expression on at least 70% of cancer cells confirmed by flow cytometry
  • Adequate CD3+ T-cell count above 120 cells per microliter of blood
  • Clinical performance status: Karnofsky score of 50% or higher for patients older than 10 years
  • Clinical performance status: Lansky score of 50% or higher for patients 10 years or younger
  • Negative pregnancy test for females of child-bearing potential
  • Normal cardiac function with left ventricular ejection fraction over 45% or shortening fraction over 28%
  • At least 60 days since autologous or allogeneic bone marrow transplant
  • At least 30 days since prior CAR therapy if no response
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sheba Medical Center

Ramat Gan, G, Israel

Actively Recruiting

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Research Team

S

Sivan Yakobi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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