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B-ALLPhase 1/2NCT04781634

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

A Phase 1/2 study testing CD19 and CD22 targeted prime CAR-T cells in people with B-ALL, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL Read more about this study

Who is it for?
Ages 2 to 75 years
Conditions the study is for
B-ALL
What is being tested?
CD19 and CD22 targeted prime CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
7 Mar 2021to 1 Jul 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
  • Failed to standard chemotherapy regimens;
  • Relapse after complete remission, high-risk and / or refractory patients ;
  • Relapse after hematopoietic stem cell transplantation;
  • For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
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  • Evidence for cell membrane CD19 or CD22 expression
  • All genders ages: 2 to 75 years
  • The expect time of survive is above 3 months;
  • KPS>60
  • No serious mental disorders ;
  • Left ventricular ejection fraction ≥50%
  • Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  • Sufficient renal function defined by creatinine clearance≤2 x ULN;
  • Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  • With single or venous blood collection standards, and no other cell collection contraindications;
  • Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Who cannot join

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD
  • The patients treatment by inhibitor of T cell
  • Pregnant or breasting-feeding women;
  • Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhi Yang, PhD contact

86-13206140093

yangzhi@precision-biotech.com

Sanbin Wang, MD contact

Sanbin1011@163.com

China1 site, 1 recruiting

  • 920th Hospital of Joint Logistics Support Force

    Kunming, Yunnan

    Sanbin Wang, MD, Sanbin1011@163.com

    Sanbin Wang, MD

    Recruiting

Other trials in China

About this study

Official title: Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

Read the detailed description

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.

There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Conditions
B-ALL
Being tested
CD19 and CD22 targeted prime CAR-T cells
Keywords
CD19, CD22, CAR-T

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD19 and CD22 targeted prime CAR-T cellsBiological

    A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

Study groups in NCT04781634
Study groupRoleWhat they receive
prime CAR- T cellsExperimentalPatients will be be treated with CD19 and CD22 prime CAR- T cells
Receives: Biological: CD19 and CD22 targeted prime CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events that related to treatment

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    Measured: 2 years

  2. The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL

    The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

    Measured: 6 months

Secondary outcomes (12)

  1. Rate of prime CAR-T cells in bone marrow

    Determine the rate of prime CAR-T cells in bone marrow by flow cytometry

    Measured: 2 years

  2. Rate of prime CAR-T cells in peripheral blood

    Determine the rate of prime CAR-T cells in peripheral blood by flow cytometry

    Measured: 2 years

  3. Quantity of prime CAR copies in bone marrow

    Determine the quantity of prime CAR copies in bone marrow by qPCR

    Measured: 2 years

  4. Quantity of prime CAR copies in peripheral blood

    Determine the quantity of prime CAR copies in peripheral blood by qPCR

    Measured: 2 years

  5. Rate of CD19 and CD22 positive cells in Bone marrow

    Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry

    Measured: 1 years

  6. Levels of IL-6 in Serum

    Serological determination of IL-6

    Measured: 3 months

  7. Levels of IL-10 in Serum

    Serological determination of IL-10

    Measured: 3 months

  8. Levels of TNF-α in Serum

    Serological determination of TNF-α

    Measured: 3 months

  9. Levels of CRP in Serum

    Serological determination of CRP

    Measured: 3 months

  10. Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL

    DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)

    Measured: 2 years

  11. Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B-ALL

    PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

    Measured: 2 years

  12. Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B-ALL

    OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start7 Mar 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781634
Sponsor's protocol ID
PBC025
Status last verified
Feb 2025
First submitted
26 Feb 2021
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD19 and CD22 targeted prime CAR-T cells in people with B-ALL, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhi Yang, PhD (86-13206140093, yangzhi@precision-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events that related to treatment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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