CD19 Negative B-cell MalignanciesPhase 1/2NCT04430530
4SCAR-T Therapy Post CD19-targeted Immunotherapy
A Phase 1/2 study testing Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 in people with CD19 Negative B-cell Malignancies, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- CD19 Negative B-cell Malignancies
- What is being tested?
- Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age older than 6 months.
- B cell malignancies relapsed after anti-CD19 immunotherapy.
- Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
- The KPS score over 80 points, and survival time is more than 1 month.
- Greater than Hgb 80 g/L.
- No contraindications to blood cell collection.
Who cannot join
- Complications with other active diseases, and difficult to assess patient response.
- Bacterial, fungal, or viral infection unable to control.
- Living with HIV.
- Active HBV and HCV infection.
- Pregnant and nursing mothers.
- Under systemic steroid use within a week of the treatment.
- Judged difficult to cooporate for continued evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Read the detailed description
Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.
Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped B cell malignancies.
- Conditions
- CD19 Negative B-cell Malignancies
- Being tested
- Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
- Keywords
- 4S CAR-T CD22, 4S CAR-T CD123, 4S CAR-T CD38, 4S CAR-T CD10, 4S CAR-T CD20, CD19 Negative B cell leukemiaB-ALL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20Biological
Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies
| Study group | Role | What they receive |
|---|---|---|
| 4SCAR-CD22/CD123/CD38/CD10/CD20 infusion | Experimental | Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies Receives: Biological: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Measured: 24 weeks
Secondary outcomes (1)
Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
Scale of CAR copies are detected by qPCR and leukemic cell burden are assessed by flow cytometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jun 2026
- Primary completion1 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19 Negative B-cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430530
- Sponsor's protocol ID
- GIMI-IRB-20008
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04430530
- Acronym / sponsor ID
- GIMI-IRB-20008
- Conditions
- CD19 Negative B-cell Malignancies
- Keywords
- 4S CAR-T CD22, 4S CAR-T CD123, 4S CAR-T CD38, 4S CAR-T CD10, 4S CAR-T CD20, CD19 Negative B cell leukemiaB-ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Detailed description
Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.
Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped B cell malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4SCAR-CD22/CD123/CD38/CD10/CD20 infusion | Experimental | Biological: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age older than 6 months.
- B cell malignancies relapsed after anti-CD19 immunotherapy.
- Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
- The KPS score over 80 points, and survival time is more than 1 month.
- Greater than Hgb 80 g/L.
Key exclusion criteria (7 listed)
- Complications with other active diseases, and difficult to assess patient response.
- Bacterial, fungal, or viral infection unable to control.
- Living with HIV.
- Active HBV and HCV infection.
- Pregnant and nursing mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies | Biological | 4SCAR-CD22/CD123/CD38/CD10/CD20 infusion |
Primary outcome
Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
Time frame: 24 weeks
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
1 secondary outcome
Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 in people with CD19 Negative B-cell Malignancies, run by Shenzhen Geno-Immune Medical Institute 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 6 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: stopped early, as of the sponsor's last update on 24 Aug 2026. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.