Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT05105867
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
A Early Phase 1 study testing Anti-CD19 Universal CAR-T Cells injection in people with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed or Refractory B-cell Non-hodgkin Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.
Trial summary
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B-cell Non-hodgkin Lymphoma
- What is being tested?
- Anti-CD19 Universal CAR-T Cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2021to 30 Nov 2024
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group Performance Status of 0 or 1；
- Expected survival time ≥12 weeks;
- Adequate hematological, renal and liver function;
- Subjects understand and voluntarily sign the informed consent form.
Who cannot join
- Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
- Cyclophosphamide or fludarabine is contraindicated for subjects ;
- Active central nervous system (CNS) involvement by malignancy；
- Active infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, 650000
Sanbin Wang, Professor, 13187424131 ext. +86, Sanbin1011@163.com
About this study
Official title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
Read the detailed description
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
- Conditions
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B-cell Non-hodgkin Lymphoma
- Being tested
- Anti-CD19 Universal CAR-T Cells injection
- Medical subject headings
- Recurrence, Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 Universal CAR-T Cells injectionBiological
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19 Universal CAR-T Cells injection | Experimental | Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion . Receives: Biological: Anti-CD19 Universal CAR-T Cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Incidence of dose-limiting toxicities as protocol-defined
Measured: Up to 4 weeks after CAR-T infusion
Secondary outcomes (1)
Objective response rate (ORR)
Objective response rate after CAR-T infusion
Measured: At 4,12,24 weeks after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start29 Sep 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd., Kunming Hope of Health Hospital
- Responsible party
- Sponsor
- Investigators
- Sanbin Wang, Professor, Principal investigator, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105867
- Sponsor's protocol ID
- GC011-411
- Status last verified
- Apr 2023
- First submitted
- 25 Oct 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05105867
- Acronym / sponsor ID
- GC011-411
- Conditions
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B-cell Non-hodgkin Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd., Kunming Hope of Health Hospital
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 3 Nov 2021 (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.
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
Detailed description
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD19 Universal CAR-T Cells injection | Experimental | Biological: Anti-CD19 Universal CAR-T Cells injectionAnti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1；
- Expected survival time ≥12 weeks;
- Adequate hematological, renal and liver function;
- Subjects understand and voluntarily sign the informed consent form.
Key exclusion criteria (4 listed)
- Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
- Cyclophosphamide or fludarabine is contraindicated for subjects ;
- Active central nervous system (CNS) involvement by malignancy；
- Active infection.
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 |
|---|---|---|
| Anti-CD19 Universal CAR-T Cells injectionAnti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion. | Biological | Anti-CD19 Universal CAR-T Cells injection |
Primary outcome
Dose Limiting Toxicities
Time frame: Up to 4 weeks after CAR-T infusion
Incidence of dose-limiting toxicities as protocol-defined
1 secondary outcome
Objective response rate (ORR)
Time frame: At 4,12,24 weeks after CAR-T infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
Related trials for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
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Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
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CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
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Phase I Safety Clinical Trial of Anti-CD19 CAR-T Therapy COL01 for the Treatment of Adults With Relapsed or Refractory B-cell Lymphoid Neoplasms: First-in-human Administration, COLIBRI.
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Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
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Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
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.
Sanbin Wang, Professor principal investigator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anti-CD19 Universal CAR-T Cells injection in people with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed or Refractory B-cell Non-hodgkin Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanbin Wang, Professor (13187424131 ext. +86, Sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: Up to 4 weeks after CAR-T infusion). 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 10 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.