Relapsed or Refractory B Cell Leukemia and LymphomaPhase 1/2NCT06834529
CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma
A Phase 1/2 study testing CAR2219-T cells in people with Relapsed or Refractory B Cell Leukemia and Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Relapsed or Refractory B Cell Leukemia and Lymphoma
- What is being tested?
- CAR2219-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 31 Jan 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed written informed consent;
- Relapsed/refractory CD19/CD22 positive B cell Leukemia or Lymphoma must be assured and meet one of the following conditions: (1) Confirmation for either CD19 or CD22 positivity using immunohistochemistry or flow cytometry; (2) B-cell tumors include the following three categories: ① B-cell acute lymphoblastic leukemia (B-ALL); Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL) (3) Refractory/recurrent B-ALL (include one of the following situations) : ① relapse within 12 months after the first remission; ② The first refractory patients who did not achieve complete remission after 2 cycles of standard chemotherapy regimen; ③ Failure to achieve complete remission or relapse after first-line or multi-line salvage chemotherapy; ④ Recurrence after hematopoietic stem cell transplantation. (4) Refractory/recurrent B-cell lymphoma (meeting the requirements of 1 of the first 4 below plus 5) : ① After 4 courses of chemotherapy prescribed by the standard protocol, the tumor has shrunk by less than 50% or the disease progression(PD); ② CR reached after standard chemotherapy, but relapse occurred within 12 months; ③ Two or more recurrence after CR; ④ Recurrence after hematopoietic stem cell transplantation; ⑤Patients must have received rituximab or another anti-CD20 monoclonal antibody (unless Investigator determines that tumor is CD20-negative) and an anthracycline-containing chemotherapy regimen.
- All genders, ages: 14 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Life expectancy ≥3 months;
- HGB≥70g/L
- Liver,kidney function and cardiopulmonary function meet the following requirements: (1) creatinine ≤1.5×ULN; (2) left ventricular ejection fraction≥50%; (3) Oxygen saturation >90%; (4) Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN;
- Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion."
Who cannot join
- Severe heart failure with left ventricular ejection fraction <50%;
- A history of severe lung function impairment;
- Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
- Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection);
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- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- History of severe allergy to biological products (including antibiotics);
- Allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with acute graft-versus-host reaction (GVHD) one month after immunosuppressant withdrawal;
- Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality
Ethics Committee, 010-66947798, ec307yy@163.com
About this study
Official title: Safety and Efficacy of CAR2219 CAR-T Cells in Treatment of Relapsed/refractory CD19/CD22 Positive B Cell Leukemia and Lymphoma
This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.
Read the detailed description
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR2219 CAR-T cell. 20 subjects with relapsed or refractory CD19/ CD22 positive B-cell Leukemia and Lymphoma will be enrolled and received CAR2219 CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.
- Being tested
- CAR2219-T cells
- Keywords
- CAR-T, B cell Leukemia, B cell Lymphoma, CD19/CD22
- Medical subject headings
- Recurrence, Leukemia, B-Cell, Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR2219-T cellsGenetic
Also called Fludarabine, Cyclophosphamide
Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10^5 /kg, the medium dose is 1×10^6 /kg, and the high dose is 2×10^6 /kg.
Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.
Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CAR2219 CAR-T cell. | Experimental | Experimental: CAR2219-T cells Therapy Investigational product: CAR2219-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD2219-CAR-T cells.
Interventions: Biological: Autologous or donor's anti-CD19 and anti-CD22 dual specific CAR-T Cells Drug: Fludarabine and Cyclophosphamide. Receives: Genetic: CAR2219-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
Measured: up to 2 years
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Measured: MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Secondary outcomes (1)
According to the objective response rate (ORR) to evaluate the efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Overall response rate (ORR) Description: Proportion of participants achieving complete response (CR) or partial response (PR) according to Lugano 2014 criteria for lymphomas and NCCN guidelines for leukemias, assessed via bone marrow biopsy (for leukemia) and PET/CT imaging (for lymphoma)
Measured: Within 3 months following infusion of CAR2219 CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 Jan 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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 Leukemia and LymphomaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834529
- Sponsor's protocol ID
- CAR2219-XYBYXB
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of CAR2219 CAR-T Cells in Treatment of Relapsed/refractory CD19/CD22 Positive B Cell Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT06834529
- Acronym / sponsor ID
- CAR2219-XYBYXB
- Keywords
- CAR-T, B cell Leukemia, B cell Lymphoma, CD19/CD22
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Feb 2025 (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 study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.
Detailed description
This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR2219 CAR-T cell. 20 subjects with relapsed or refractory CD19/ CD22 positive B-cell Leukemia and Lymphoma will be enrolled and received CAR2219 CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This is a single arm treatment of CAR2219 CAR-T cell. | Experimental | Genetic: CAR2219-T cellsExperimental: CAR2219-T cells Therapy Investigational product: CAR2219-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD2219-CAR-T cells. Interventions: Biological: Autologous or donor's anti-CD19 and anti-CD22 dual specific CAR-T Cells Drug: Fludarabine and Cyclophosphamide. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent;
- Relapsed/refractory CD19/CD22 positive B cell Leukemia or Lymphoma must be assured and meet one of the following conditions: (1) Confirmation for either CD19 or CD22 positivity using immunohistochemistry or flow cytometry; (2) B-cell tumors include the following three categories: ① B-cell acute lymphoblastic leukemia (B-ALL); Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL) (3) Refractory/recurrent B-ALL (include one of the following situations) : ① relapse within 12 months after the first remission; ② The first refractory patients who did not achieve complete remission after 2 cycles of standard chemotherapy regimen; ③ Failure to achieve complete remission or relapse after first-line or multi-line salvage chemotherapy; ④ Recurrence after hematopoietic stem cell transplantation. (4) Refractory/recurrent B-cell lymphoma (meeting the requirements of 1 of the first 4 below plus 5) : ① After 4 courses of chemotherapy prescribed by the standard protocol, the tumor has shrunk by less than 50% or the disease progression(PD); ② CR reached after standard chemotherapy, but relapse occurred within 12 months; ③ Two or more recurrence after CR; ④ Recurrence after hematopoietic stem cell transplantation; ⑤Patients must have received rituximab or another anti-CD20 monoclonal antibody (unless Investigator determines that tumor is CD20-negative) and an anthracycline-containing chemotherapy regimen.
- All genders, ages: 14 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Life expectancy ≥3 months;
Key exclusion criteria (10 listed)
- Severe heart failure with left ventricular ejection fraction <50%;
- A history of severe lung function impairment;
- Combined with other advanced malignant tumors;
- Complicated with severe infection that could not be effectively controlled;
- Severe autoimmune disease or congenital immune deficiency;
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 |
|---|---|---|
| CAR2219-T cellsAlso: Fludarabine, CyclophosphamideGenetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10^5 /kg, the medium dose is 1×10^6 /kg, and the high dose is 2×10^6 /kg. Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells. | Genetic | This is a single arm treatment of CAR2219 CAR-T cell. |
Primary outcome
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Time frame: up to 2 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Time frame: MTD will be determined based on DLTs observed during the first 28 days of study treatment.
1 secondary outcome
According to the objective response rate (ORR) to evaluate the efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.
Time frame: Within 3 months following infusion of CAR2219 CAR-T cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
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 CAR2219-T cells in people with Relapsed or Refractory B Cell Leukemia and Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences 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 8 inclusion and 10 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 19 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 Hongmei Ning, Dr (+86 01066947164, ninghongmei72@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma. (time frame: up to 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?
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 19 Feb 2025.