B-cell Acute Lymphoblastic LeukemiaPhase 1NCT07838714
Dual-Targeted Umbilical Cord Blood CAR-T Cells Against CD19 and CD22 for the Treatment of Relapsed or Refractory Acute B-Cell Lymphoblastic Leukemia
A Phase 1 study testing Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells, Fludarabine and Cyclophosphamide in people with B-cell Acute Lymphoblastic Leukemia, run by Ruijin Hospital at 1 site in China.
Trial summary
This investigator-initiated, prospective, single-arm, phase I dose-escalation trial aims to evaluate the safety and tolerability of anti-CD19/CD22 dual-target cord blood-derived CAR-T cells in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who have failed prior therapies, with the goal of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2026to 30 Mar 2028
- Phase
- Phase 1
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient or their legally authorized guardian has signed the informed consent form (ICF), indicating understanding of the purpose and procedures of this clinical trial and willingness to participate.
- Age between 18 and 75 years, male or female.
- Diagnosis of relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) according to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 edition).
- Leukemic cells confirmed to express CD19 and/or CD22 by flow cytometry.
- ECOG performance status 0-2.
- Life expectancy ≥12 weeks.
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- Adequate organ function at screening, meeting all of the following laboratory criteria:
- Hematology: absolute neutrophil count (ANC) ≥1×10⁹/L; absolute lymphocyte count (ALC) ≥0.3×10⁹/L; platelet count ≥20×10⁹/L; hemoglobin ≥60 g/L.
- Hepatic function: ALT and AST ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5× ULN.
- Renal function: creatinine clearance (CrCl) ≥40 mL/min (by Cockcroft-Gault formula).
- Coagulation: fibrinogen ≥1.0 g/L; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.
- Oxygen saturation >91%.
- Left ventricular ejection fraction (LVEF) ≥50%.
- The subject and their spouse agree to use effective contraceptive measures (excluding rhythm method) from ICF signing through 1 year after CAR-T cell infusion.
Who cannot join
- Active graft-versus-host disease (GVHD) or autoimmune disease requiring long-term immunosuppressive therapy.
- Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 7 days prior to screening. Physiologic replacement, topical, and inhaled steroids are permitted.
- Hypertension not controllable with medication.
- Severe cardiac disease, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA class ≥III), or severe arrhythmia.
- Unstable systemic disease as judged by the investigator, including but not limited to: severe hepatic, renal, or metabolic disease requiring medication.
- Malignancy other than B-ALL within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery.
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- History of solid organ transplantation.
- Planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate).
- Receipt of other interventional investigational drugs within 1 month prior to ICF signing.
- Uncontrolled active infection.
- Positive for HBsAg, or positive for HBcAb with detectable HBV DNA in peripheral blood; positive for HCV antibody with detectable HCV RNA; positive for HIV antibody; positive for CMV DNA; positive for syphilis serology.
- Pregnant or breastfeeding women.
- Psychiatric illness, consciousness disorder, or central nervous system disease.
- Other conditions deemed unsuitable for enrollment by the investigator.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jin Wang, PhD, +86 13524945202, jinwang@shsmu.edu.cn
About this study
Official title: A Single-Center Phase I Clinical Trial of Dual-Targeted Umbilical Cord Blood CAR-T Cells Against CD19 and CD22 for the Treatment of Relapsed or Refractory Acute B-Cell Lymphoblastic Leukemia
This investigator-initiated, prospective, single-arm, phase I dose-escalation trial aims to evaluate the safety and tolerability of anti-CD19/CD22 dual-target cord blood-derived CAR-T cells in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who have failed prior therapies, with the goal of reducing antigen-escape relapse and overcoming poor autologous T-cell fitness through the use of universally available umbilical cord blood T cells.
Read the detailed description
Patients with relapsed/refractory B-cell acute lymphoblastic leukemia who meet eligibility criteria will receive fludarabine (30 mg/m²/d) and cyclophosphamide (300 mg/m²/d) for three consecutive days as lymphodepleting conditioning, followed by a single intravenous infusion of anti-CD19/CD22 dual-target cord blood-derived CAR-T cells. Dose assignment follows a "3+3" escalation design across three dose levels (4×10⁶, 8×10⁶, and 12×10⁶ CAR-T/kg, ±20%). Dose-limiting toxicity will be assessed during the first 14 days post-infusion to determine the maximum tolerated dose. After CAR-T infusion, patients will be monitored for safety and efficacy at protocol-specified time points through 3 months, with long-term follow-up continuing up to 15 years post-infusion. A total of 18 patients will be enrolled.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells, Fludarabine, Cyclophosphamide
- Keywords
- Relapsed/refractory B-cell acute lymphoblastic leukemia, CAR-T cell, Umbilical cord blood
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19/CD22 Dual-Target Cord Blood CAR-T CellsBiological
Genetically modified umbilical cord blood-derived T cells expressing chimeric antigen receptors targeting both CD19 and CD22. Administered as a single intravenous infusion on Day 0 following lymphodepleting chemotherapy. Dose levels: 4.0×10⁶, 8.0×10⁶, and 12.0×10⁶ CAR-T/kg (±20%) according to 3+3 dose escalation design.
FludarabineDrug
30 mg/m² intravenous infusion over 30 minutes once daily for 3 consecutive days as lymphodepleting preconditioning prior to CAR-T cell infusion.
CyclophosphamideDrug
300 mg/m² intravenous infusion over 30 minutes once daily for 3 consecutive days as lymphodepleting preconditioning prior to CAR-T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells | Experimental | A single intravenous infusion of anti-CD19/CD22 dual-target umbilical cord blood-derived CAR-T cells administered on Day 0, following lymphodepleting chemotherapy with fludarabine (30 mg/m²/day) and cyclophosphamide (300 mg/m²/day) for three consecutive days. Dose escalation follows a 3+3 design across three dose levels (4.0×10⁶, 8.0×10⁶, and 12.0×10⁶ CAR-T/kg, ±20%). All subjects receive the same investigational product; no comparator arm is included. Receives: Biological: Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Dose-Limiting Toxicity (DLT)
DLT is defined as treatment-related adverse events occurring within 14 days post-infusion. Non-hematologic DLT: Grade ≥3 toxicity not reducible to ≤ Grade 1 within 72 hours. Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) persisting >21 days, not attributable to underlying disease. Predefined exclusion criteria include tumor lysis syndrome, electrolyte disturbances, hypogammaglobulinemia, transient laboratory abnormalities, febrile neutropenia, and others per protocol. CRS/ICANS graded per ASTCT 2019, aGVHD per modified Glucksberg, other AEs per CTCAE v5.0.
Measured: Within 14 days after CAR-T cell infusion
Secondary outcomes (10)
Objective Response Rate (ORR)
ORR is the proportion of subjects achieving CR/CRi at 1 and 3 months post-infusion. Efficacy assessed by bone marrow examination per international acute leukemia response criteria.
Measured: 1 and 3 months post-infusion
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate is the proportion of subjects achieving MRD-negative status by flow cytometry at 1 and 3 months post-infusion.
Measured: 1 and 3 months post-infusion
Complete Remission (CR) Rate
CR rate is the proportion achieving CR. Efficacy assessed by bone marrow examination per international acute leukemia response criteria.
Measured: 1 and 3 months post-infusion
Progression-Free Survival (PFS)
PFS is defined as time from infusion to disease progression, relapse, or death. Median PFS and 12-/24-month PFS rates will be estimated by Kaplan-Meier method.
Measured: From infusion up to 24 months
Overall Survival (OS)
OS is defined as time from infusion to death from any cause. Median OS and 12-/24-month OS rates will be estimated by Kaplan-Meier method.
Measured: From infusion up to 24 months
CAR-T Cell Expansion and Persistence
CAR-T cell levels and vector copy number (VCN) in peripheral blood will be measured.
Measured: Up to 90 days post-infusion
CAR-T Cell Expansion and Persistence
PK parameters: Cmax(Peak Plasma Concentration)
Measured: Up to 90 days post-infusion
CAR-T Cell Expansion and Persistence
PK parameters: Tmax
Measured: Up to 90 days post-infusion
CAR-T Cell Expansion and Persistence
PK parameters: AUC₀-₂₈d, AUC₀-₉₀d.
Measured: Up to 90 days post-infusion
CAR-T Cell Expansion and Persistence
Proportion of subjects with detectable CAR-T cells at 3 and 6 months, and duration of persistence will be recorded.
Measured: At 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start13 May 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838714
- Sponsor's protocol ID
- RJ-ALL 2026-B01
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No