CD19 and CD22 Sequential CAR-T Versus CD19 CAR-T Bridging to Transplant in Refractory or Relapsed B-ALL
This multi-center Chinese study compares two strategies for patients with refractory or relapsed B-cell acute lymphoblastic leukemia: sequential CD19 and CD22 CAR-T cell infusion versus CD19 CAR-T followed by stem cell transplant. CancerFax helps patients and families organize medical records, coordinate remote review, and explore whether this pathway may be appropriate.
About This Clinical Trial
B-cell acute lymphoblastic leukemia (B-ALL) is one of the most common blood cancers in children and a serious diagnosis in adolescents and adults. While initial treatment leads to remission in many patients, those whose disease comes back (relapsed) or does not respond to standard therapy (refractory) face a much harder path. For these patients, finding effective options is one of the most pressing challenges in modern hematology.
CD19-targeted CAR-T cell therapy has changed outcomes for many patients with refractory or relapsed B-ALL. However, a significant number of patients eventually relapse after CD19 CAR-T, often because their leukemia cells lose CD19 expression. Adding a second CAR-T product targeting CD22, another antigen commonly found on B-ALL cells, is a strategy researchers believe may reduce this kind of antigen-escape relapse.
This pragmatic multi-center trial at Beijing GoBroad Hospital and partner sites compares two real-world treatment pathways for patients aged 1 to 70 with refractory or relapsed B-ALL. Arm 1 receives sequential CD19 and CD22 CAR-T cell infusions. Arm 2 receives CD19 CAR-T cell infusion followed by hematopoietic stem cell transplantation (HSCT). A third group of patients who choose CD19 CAR-T without consolidation is also followed for comparison.
The primary goal is to measure two-year event-free survival between the two main strategies. Secondary measurements include overall response rate at three months, duration of remission, overall survival, safety, CAR-T cell persistence in blood, and B-cell recovery. The trial plans to enroll 353 patients and is expected to follow participants for up to 15 years.
Whether sequential CD19 plus CD22 CAR-T infusion can match or exceed the outcomes of CD19 CAR-T followed by stem cell transplant in patients with refractory or relapsed B-ALL.
Trial at a Glance
A quick summary of the trial design. This is a snapshot for orientation, not a confirmation of eligibility.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
CAR-T cell therapy is a form of cellular immunotherapy that reprograms a patient's own T cells in a laboratory to recognize and destroy cancer cells. This trial studies a sequential strategy in which two CAR-T products, one targeting CD19 and another targeting CD22, are infused one after the other to reduce the chance of the leukemia coming back through antigen loss.
The comparison arm uses a CD19 CAR-T infusion followed by hematopoietic stem cell transplantation (HSCT), which has historically been the consolidation approach for many high-risk patients.
How the therapy works (in simple terms)
T cells are collected from the patient through a procedure called apheresis. In the laboratory, these T cells are genetically modified to express a chimeric antigen receptor that targets either CD19 or CD22, proteins found on B-ALL leukemia cells. The cells are then expanded in number, returned to the patient through a vein, and continue to multiply inside the body to attack the cancer. By using two separate CAR-T products one after the other, the sequential approach aims to target the leukemia from two different angles, which may reduce relapse driven by loss of a single antigen.
Confirmation of B-ALL diagnosis, CD19 and CD22 expression on blasts, prior treatment history, organ function, and absence of conditions that would prevent participation.
T cells are collected from the patient's blood through a vein over several hours. The collected cells are sent to the manufacturing lab.
T cells are genetically modified in the lab to recognize CD19 (and separately CD22 for sequential CAR-T patients) and expanded to clinical doses. This usually takes a few weeks.
A short course of chemotherapy is given before infusion to create space in the immune system, helping CAR-T cells expand and engage the leukemia.
In the sequential arm, CD19 CAR-T is infused first, followed by CD22 CAR-T. In the comparison arm, only CD19 CAR-T is infused, with hematopoietic stem cell transplant as later consolidation.
Patients are monitored for cytokine release syndrome, neurological events, infections, and response. Follow-up extends for up to 15 years to track durability of response, side effects, and survival.
While CD19 CAR-T therapies are approved for B-ALL in some countries, the sequential CD19 plus CD22 CAR-T approach studied here is still under clinical evaluation.
Who This Trial May Be For
This trial may be most relevant for children, adolescents, and adults whose B-cell ALL has come back or has not responded to standard treatment, and whose leukemia cells still express both CD19 and CD22. Final relevance always depends on the trial team's review of complete records.
Patients diagnosed with B-cell acute lymphoblastic leukemia who did not achieve remission after prior therapy, did not respond to at least two lines of TKI therapy, or have had one or more relapses.
Leukemia blasts must show greater than 80% CD19 and CD22 positivity by flow cytometry. Persistent MRD positivity for more than three months after last therapy in CD19/CD22-positive high-risk B-ALL is also eligible.
The trial is open to pediatric, adolescent, young adult, and older adult patients within this age range, which is broader than many CAR-T trials worldwide.
Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group scale, indicating the patient is well enough to undergo apheresis, lymphodepletion, and CAR-T infusion.
Sufficient life expectancy in the investigator's judgment to allow CAR-T manufacturing time and meaningful response assessment.
Patients and families need to be prepared for an extended inpatient stay in Beijing or one of the partner sites, with translation, visa, and accommodation logistics to plan for in advance.
Eligibility Criteria
These criteria are summarized from the trial registry. Meeting one or more of them does not guarantee enrollment. Final eligibility is decided by the trial team only after detailed review.
check_circleInclusion Criteria โ May Be Eligible
- โPatients diagnosed with primary refractory or relapsed B-cell ALL (NCCN v2.2023 reference), confirmed by hematopathology review including flow cytometric immunophenotyping, minimal residual disease analysis, and karyotyping
- โRefractory/relapsed definition: did not achieve complete remission after previous therapy, did not achieve complete remission after at least two lines of TKI therapy, or had one or more relapses
- โCD19 and CD22 positive disease, with more than 80% positivity on leukemia blasts by flow cytometry
- โHigh-risk CD19+ and CD22+ B-ALL with persistent MRD positivity for more than three months after last therapy is also eligible
- โAge 1 to 70 years
- โECOG performance status 0 to 2
- โLife expectancy of at least 60 days in the investigator's judgment
- โNo serious allergic constitution
- โVoluntary informed consent signed by patients aged 8 to 70, and by legal representatives or guardians for pediatric patients under 18
cancelExclusion Criteria โ May Not Be Eligible
- รIntracranial hypertension or unconscious state
- รAcute heart failure or severe arrhythmia
- รAcute respiratory failure
- รOther types of active malignant tumors
- รDiffuse intravascular coagulation
- รSerum creatinine and/or blood urea nitrogen more than 1.5 times the upper normal value
- รSepsis or other uncontrolled infection
- รUncontrolled diabetes mellitus
- รSevere psychological disorder
- รObvious cranial lesions on cranial MRI
- รMore than 20 leukemic cells per microliter in cerebrospinal fluid
- รMore than 30% leukemic cells in peripheral blood
- รOrgan transplant recipients
- รPregnant or breastfeeding patients
- รActive uncontrolled infection including hepatitis B, hepatitis C, HIV, or treponema pallidum
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
CAR-T trial review for B-ALL requires more detailed records than most oncology consultations. Clear and complete documents allow the trial team to assess eligibility faster and more accurately. CancerFax helps families organize and translate these documents when needed.
How the Trial Process May Work
Sequential CAR-T trials are more complex than most oncology trials and involve multiple coordinated steps. Knowing the sequence helps families prepare for the time and logistics involved.
Remote review of medical records, pathology, flow cytometry, and treatment history. CancerFax can help organize and translate documents for the trial team.
The trial team gives a preliminary view on whether the case appears suitable. This is not final enrollment but indicates whether to proceed to on-site evaluation.
Travel and visa arrangements for the patient and family, followed by hospital admission for confirmatory tests including fresh flow cytometry, organ function, and infectious disease screening.
Detailed discussion of the two main arms (sequential CD19+CD22 CAR-T versus CD19 CAR-T plus transplant) and informed consent based on the patient or guardian's preference.
T cell collection, CAR-T manufacturing in the lab over a few weeks, short course of lymphodepleting chemotherapy, then CAR-T infusion (sequential CD19 then CD22 in Arm 1, or CD19 CAR-T followed later by HSCT in Arm 2).
Inpatient observation for cytokine release syndrome, ICANS, infections, and response, followed by structured follow-up visits extending up to 15 years to track durability and late effects.
Potential Benefits
Participating in a clinical trial can offer access to therapies and combinations not yet widely available. For families considering CAR-T for refractory or relapsed B-ALL, this trial is one of the larger pragmatic studies comparing two consolidation strategies in real-world Chinese practice.
Sequential CD19 and CD22 CAR-T is not yet a standard approved approach in most countries. This trial offers access to a structured protocol at an experienced Chinese center.
The trial is led by Beijing GoBroad Hospital with six partner sites including Ruijin Hospital, providing experienced multidisciplinary teams for CAR-T and transplant.
Participants are monitored over an extended follow-up period, with assessment of CAR-T persistence, B-cell recovery, and late effects, which patients receiving off-protocol therapy often do not get.
The trial requires confirmed CD19 and CD22 positivity, ensuring that the targeted antigens are present on the patient's leukemia before committing to therapy.
Unlike many CAR-T trials that limit enrollment to children or adults only, this study accepts patients from 1 to 70 years, allowing access for AYA and older adult patients.
Pragmatic comparative studies like this one help build evidence on how sequential CAR-T compares with CAR-T plus transplant in real clinical practice.
Participation in this trial may or may not directly benefit an individual patient. Realistic expectations, careful family discussion, and clear understanding of risks are essential before deciding.
Risks and Side Effects
CAR-T cell therapy is a powerful treatment, but it carries serious and well-documented risks. Sequential CAR-T adds an additional infusion, and the comparison arm involves the risks of allogeneic stem cell transplantation. Every patient is monitored closely, but families should understand the major potential risks in advance.
CRS is an immune over-activation that causes fever, low blood pressure, low oxygen, and organ stress. It can be mild or life-threatening and may require ICU care, tocilizumab, and steroids. Sequential CAR-T can produce CRS after either infusion.
Immune effector cell-associated neurotoxicity syndrome (ICANS) can cause confusion, language problems, tremor, or in severe cases seizures and reduced consciousness. Most cases reverse with treatment, but careful monitoring is essential.
Lymphodepletion and CAR-T expansion cause low neutrophils, low platelets, and anemia. This raises the risk of bacterial, viral, and fungal infections, sometimes prolonged for months.
By design, CD19 and CD22 CAR-T deplete normal B cells along with leukemia cells. This can leave patients dependent on immunoglobulin replacement for an extended period.
The transplant arm carries the additional risks of allogeneic HSCT, including graft-versus-host disease, infections, organ toxicity, and transplant-related mortality.
Sequential CD19 and CD22 CAR-T is still under clinical evaluation. Long-term risks, including secondary cancers and late immune effects, are being monitored through the 15-year follow-up.
Time away from home, travel and accommodation in China, possible trial discontinuation, and no guarantee of response are real considerations. Families should weigh these carefully with the treating oncologist and the trial team.
Trial Location and Hospital Information
The trial is conducted at Beijing GoBroad Hospital in Beijing, with six partner sites across China including Ruijin Hospital in Shanghai, The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine in Shanghai, Shanghai Liquan Hospital, the Central People's Hospital of Zhanjiang, and the First Affiliated Hospital of Guangxi Medical University. Treatment is delivered as an inpatient procedure, and patients should plan for an extended stay near the treating site.
International patients typically need a valid passport and Chinese medical treatment visa, translated medical records and pathology reports, remote pre-screening review by the trial team, accommodation arrangements near the hospital, and on-the-ground translation support. CancerFax coordinates these elements end to end, including hospital communication, document organization, visa support, and post-treatment follow-up planning.
Costs, Trial Coverage, and Patient Expenses
Costs for CAR-T trials in China vary by site, sponsor support, and whether the patient is local or international. Some elements may be covered under the trial, while others are typically the family's responsibility. CancerFax helps families understand the expected cost categories before committing to travel.
โ VERIFY: Sponsor coverage details for this trial are not publicly listed. CancerFax helps obtain written confirmation from the trial team on what is covered and what is not, before any family commits to travel.
Standard Treatment vs Clinical Trial
Standard treatment and clinical trial participation each have a place in r/r B-ALL care. The right choice depends on disease characteristics, prior treatments, the patient's overall condition, and the family's preferences. This comparison is a general guide to help frame discussion with the treating oncologist.
How CancerFax Helps Patients Explore This Trial
CancerFax is a specialist cancer patient-navigation and advanced cancer treatment access platform. For families considering CAR-T trials in China, we help review the medical case, organize and translate records, coordinate with hospitals and trial teams, and guide every step from initial review through travel and follow-up.
We review pathology, bone marrow reports, flow cytometry, cytogenetics, and treatment history to understand whether the case may be relevant to this CAR-T trial.
We help share records with the trial team at Beijing GoBroad Hospital, follow up on questions, and clarify next steps after preliminary assessment.
We coordinate communication between the patient or referring physician and the trial team, helping bridge language and time-zone differences.
We help with medical visa arrangements, hospital admission planning, accommodation near the hospital, and on-the-ground translation support.
If this trial is not the right fit, we help explore other CAR-T trials, approved therapies, or related cell therapy options in China and elsewhere.
From first message to post-treatment follow-up planning back in the home country, CancerFax stays involved throughout the patient's journey.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
If this trial may be relevant to your family, the questions below can help guide a meaningful discussion with the trial team and the treating oncologist. Informed decision making is one of the most important steps in considering CAR-T therapy.
Frequently Asked Questions
Want to Know Whether This Trial May Be Relevant?
If you or your child has refractory or relapsed B-cell ALL, CancerFax can help review the medical case, organize and translate records, and coordinate with the trial team at Beijing GoBroad Hospital and partner sites in China.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
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ยฉ CancerFax ยท Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.