Injecting RD06-03 CART cells to treat relapsed or refractory B-lymphoblastic leukemia

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With Relapsed or Refractory B-lymphoblastic Leukemia

This study is testing whether RD06-03 CART cell injections can safely help people with relapsed or hard-to-treat B-lymphoblastic leukemia.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 3 Years to 70 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (other gov)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT06307600 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of RD06-03 CART cell injections in patients with relapsed or refractory acute B-lymphoblastic leukemia (B-ALL). It includes a dose escalation phase to evaluate dose-limiting toxicity (DLT) followed by an efficacy exploration phase lasting up to one year. After assessing safety, researchers may expand the number of cases in specific dose groups based on treatment responses, with a maximum of 12 cases allowed. The study aims to provide insights into the potential benefits of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 3 to 70 with relapsed or refractory acute B-cell lymphoblastic leukemia.

Not a fit: Patients who have not previously received at least two tyrosine kinase inhibitors or those with specific TKI-resistant mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat B-ALL.

How similar studies have performed: Other studies using CART cell therapies have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

* Aged ≥3 and ≤70 years, gender and race unrestricted.
* Bone marrow examination confirms the diagnosis of acute B-cell lymphoblastic leukemia (B-ALL) and meets one of the following conditions:

Relapsed B-ALL: ① Relapse within 12 months after the first remission; or ② Relapse after salvage chemotherapy in first-line/multi-line treatment; or ③ Relapse after autologous or allogeneic hematopoietic stem cell transplantation; Refractory B-ALL: ① Failure to achieve complete remission after 2 cycles of standardized induction chemotherapy; or ② Failure to achieve complete remission after salvage chemotherapy in first-line/multi-line treatment;

* Ph+ALL subjects are eligible if they meet one of the following criteria: ① Relapse or refractory after receiving at least 2 tyrosine kinase inhibitors (TKIs) treatments; if accompanied by TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I, subjects are not required to receive at least two TKI treatments; or ② Unable to tolerate TKI treatment; or ③ Contraindications to TKI treatment.
* The proportion of bone marrow blasts during the screening period is ≥5% (morphological).Expression of CD19 on bone marrow or peripheral blood tumor cells is detected during the screening period.
* Organ function and laboratory tests meet the following criteria:

Serum total bilirubin \<2× upper limit of normal (ULN), serum ALT and AST both \<3× ULN, serum creatinine \<1.5× ULN; Coagulation function: International normalized ratio (INR) ≤1.5× ULN, or prothrombin time (PT) ≤1.5× ULN; Transthoracic echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; Resting oxygen saturation (SpO2) ≥92% in ambient air; Estimated survival period of more than 3 months;

* ECOG score 0-2;
* Fertile women must agree to use highly effective contraception from at least 28 days before leukapheresis to 6 months after CAR-T cell infusion. Their partners, fertile men, must agree to use effective barrier contraception from the start of leukapheresis to 6 months after CAR-T cell infusion, and should not donate semen or sperm during the entire trial period.

Exclusion Criteria:

* Suffering from genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes;
* History of allergy to any component of the cellular product;
* Presence of active central nervous system leukemia (CNSL) at screening;
* Patients with purely extramedullary relapse;
* Received allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months before screening or experienced grade II to IV active graft-versus-host disease (GVHD) within 4 weeks before infusion;
* Significant cardiovascular dysfunction within 12 months before screening, including but not limited to: New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias.

Presence or suspicion of uncontrollable active infection requiring intravenous therapy (excluding simple urinary tract infections, bacterial pharyngitis);

* Subjects with a history of other primary cancers, excluding the following:

Non-melanoma skin cancers such as basal cell carcinoma that have been cured by resection; Cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ with disease-free survival ≥2 years after adequate treatment;

* Subjects with autoimmune diseases requiring treatment, immunodeficiency, or requiring immunosuppressive therapy;
* Received live attenuated vaccines within 4 weeks before screening, or planned to receive live attenuated vaccines during the study.

Where this trial is running

Hefei, Anhui and 1 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (RECRUITING)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoyu Zhu, phd — Anhui Provincial Hospital
• Study coordinator: Xiaoyu Zhu, phd

Conditions: B Lymphoblastic Leukemia/Lymphoma