CClinicalTrials.gg
Sign In
CompletedNCT04788472Updated Oct 17, 2024

Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL

A Phase 2 interventional study of CAR-T cells targeting CD19 and CD22 in B-Cell Acute Lymphoblastic Leukemia, Adult, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Zhejiang University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Clinical Trial for the Efficacy and Safety of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Positive B-cell Acute Lymphoblastic Leukemia

Read the detailed description

This study was designed as a prospective, open-label, single-center study. It aims to evaluate the efficacy and safety of CD19 CAR-T cells in combination with dasatinib for the treatment of newly diagnosed Ph-positive B-cell acute lymphoblastic leukemia in adult.

02

Conditions studied

  • B-Cell Acute Lymphoblastic Leukemia, Adult

Keywords

  • CD19 CAR-T
  • CD22 CAR-T
  • Ph Chromosome Positive
  • B-ALL
  • Newly diagnosed
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 28 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old;
  2. Subjects with a diagnosis of B-cell acute lymphoblastic leukemia according to the 2016 edition of the WHO classification criteria for acute leukemia;
  3. Subjects whose chromosomal and fusion gene analysis showed positivity for the Ph chromosome, BCR/ABL1 fusion gene;
  4. Leukemia cells were CD19 and CD22 positive;
  5. Patients with newly diagnosed B-ALL were not treated with standard chemotherapy regimens;
  6. Serum total bilirubin ≤ 51 mol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L;
  7. Echocardiography showed a left ventricular ejection fraction (LVEF) ≥50%;
  8. Subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen;
  9. The prognosis for survival is more than 3 months;
  10. ECOG score 0-2;
  11. Subjects volunteered to participate in this trial and signed an informed consent form.

Exclusion criteria

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for enrollment in this trial:

  1. Those with a history of epilepsy or other central nervous system disorders;
  2. Those with a history of prolonged QT period or severe cardiac disease;
  3. Women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known);
  4. Those with uncontrolled active infection;
  5. Active hepatitis B or hepatitis C virus infection;
  6. Those who have previously used any gene therapy product;
  7. Those with insufficient amplification (\<5-fold) in response to CD3/CD28 co-stimulatory signals;
  8. Creatinine > 2.5 mg/dl or ALT / AST > 3 times the upper limit of the normal range or bilirubin > 2.0 mg/dl;
  9. Those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment;
  10. HIV-infected persons;
  11. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    CAR-T therapy

    Administration of CD19 and CD22 CAR T-cells

    Drug: CAR-T cells targeting CD19 and CD22

Interventions

  • DrugCAR-T cells targeting CD19 and CD22

    Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion

06

What researchers measure

Primary outcomes

  1. Complete molecular response (CMR) rate

    Complete molecular response (CMR) rate after CD19 CAR-T cell therapy

    Time frame: Up to 1 month after CAR-T cells infusion

Secondary outcomes

  1. Complete molecular response (CMR) rate

    Complete molecular response (CMR) rate after CD22 CAR-T cell therapy

    Time frame: Up to 1 month after CAR-T cells infusion

  2. Leukemia-free survival (LFS)

    From the complete remission to the occurrence of any event, including death, relapse (any one occurs first), and the last visit

    Time frame: Up to 2 years after CD19 CAR-T cells infusion

  3. Overall survival (OS)

    From the first infusion of CD19 CAR-T cells to death or the last visit

    Time frame: Up to 2 years after CD19 CAR-T cells infusion

  4. cumulative incidence of relapse (CIR)

    From the complete remission to relapse

    Time frame: Up to 2 years after CD19 CAR-T cells infusion

  5. Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events (Safety and Tolerability)

    Time frame: Through study completion, an average of 2 years

  6. Characterization of relapse

    Including expression of CD19, CD22 and mutations in the ABL1 gene

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 site
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04788472
Lead sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
Responsible party
He Huang (Professor, Zhejiang University) — Principal investigator
First posted
Mar 9, 2021
Start date
Mar 5, 2021
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024
Last update
Oct 17, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Zhejiang University

Start the discussion