Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaEarly Phase 1NCT04034446
CD19-CD22 Chimeric Antigen Receptor T (CAR-T) Cell for Treatment of B Cell Acute Lymphoblastic Leukemia (B-ALL)
A Early Phase 1 study testing CD19-CD22 CAR-T cells in people with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
- What is being tested?
- CD19-CD22 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2019to 1 Dec 2020
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent is signed by a subject or his lineal relation.
- Age 3 and older.
- Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
- Relapsed or refractory B-cell ALL
- Relapse within 12 months of first remission
- Without remission after 2 cycles of induction chemotherapy regimen.
Show all 21Show fewer
- Without remission or relapse after salvage treatments.
- Any BM relapse after autologous stem cell transplantation (ASCT).
- Without remission or relapse after any prior CD19 targeted therapy;
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening；
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2.
- Adequate organ function defined as:
- Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) ≤3 ULN;
- Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome;
- Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible.
- A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min（Cockcroft and Gault）
- Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air.
- Absolute lymphocyte count ≥0.3 x 10⁹/L.
- Women of child-bearing potential and all male participants must use highly effective methods of contraception for a period of 1 year after the CD19-CD22 CAR-T cells infusion.
Who cannot join
- Active central nervous system leukemia
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
- Major surgery within ≤ 4 weeks before enrollment.
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
- Impaired cardiac function:
Show all 17Show fewer
- Left Ventricular Ejection Fraction (LVEF) ≤45%;
- III/IV congestive heart failure (NYHA);
- Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
- Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)（QTc using Bazett's formula (QTcB)=QT/RR^0.5）;
- Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
- Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
- Patients with a history of epilepsy or other active central nervous system diseases.
- Life expectancy < 12 weeks.
- Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.
- Subjects who are receiving systemic steroid treatment and who have been determined by the researchers to require long-term treatment with systemic steroids during treatment, and subjects treated with systemic steroids must be excluded < 72 hours prior to CNCT19 infusion (except inhalation or local use).
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
Read the detailed description
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.
- Being tested
- CD19-CD22 CAR-T cells
- Keywords
- Relapsed, Refractory, B-ALL
- Medical subject headings
- Recurrence, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-CD22 CAR-T cellsBiological
0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Single dose of CD19-CD22 CAR-T cells Receives: Biological: CD19-CD22 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 24 months
Overall remission rate (ORR)
Measured: 3 months
Secondary outcomes (6)
Response at Day 28 days
Measured: 1 month
Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.
Measured: 6 months
Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow
Measured: 6 months
Relapse-free survival (RFS)
Measured: 24 months
Duration of remission (DOR)
Measured: 24 months
Overall survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start30 Sep 2019
- Primary completion21 Jul 2020
- Study completion1 Dec 2020
Why it stopped: Due to adjustments in the company's strategy, the research and development of this project has been terminated.
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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034446
- Sponsor's protocol ID
- QT2019005
- Status last verified
- May 2020
- First submitted
- 24 Jul 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Feasibility and Safety Study of Bispecific CD19-CD22 CAR-T Cell in the Treatment of Relapsed or Refractory B-ALL
- ClinicalTrials.gov ID
- NCT04034446
- Acronym / sponsor ID
- QT2019005
- Keywords
- Relapsed, Refractory, B-ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to adjustments in the company's strategy, the research and development of this project has been terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 26 Jul 2019 (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 is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
Detailed description
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CD19-CD22 CAR-T cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: CD19-CD22 CAR-T cellsSingle dose of CD19-CD22 CAR-T cells |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Informed consent is signed by a subject or his lineal relation.
- Age 3 and older.
- Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
- Relapsed or refractory B-cell ALL
- Without remission or relapse after any prior CD19 targeted therapy;
Key exclusion criteria (17 listed)
- Active central nervous system leukemia
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
- Major surgery within ≤ 4 weeks before enrollment.
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
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 |
|---|---|---|
| CD19-CD22 CAR-T cells0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion. | Biological | A |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 24 months
Overall remission rate (ORR)
Time frame: 3 months
6 secondary outcomes
Response at Day 28 days
Time frame: 1 month
Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.
Time frame: 6 months
Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow
Time frame: 6 months
Relapse-free survival (RFS)
Time frame: 24 months
Duration of remission (DOR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Due to adjustments in the company's strategy, the research and development of this project has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Related trials for Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
RecruitingPhase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1/2
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Not yet recruitingPhase 1/2
CD19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase I/II Study
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
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.
Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia, Lymphoid Malignancies
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 Early Phase 1 study testing CD19-CD22 CAR-T cells in people with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 21 inclusion and 17 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 3 Jun 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 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?
The study was stopped early (reason given: Due to adjustments in the company's strategy, the research and development of this project has been terminated.). 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 24 months). 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?
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 3 Jun 2025.