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Tests treatment safety and results for B Lymphoblastic Leukemia/Lymphoma
Official title The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06307600
What this study is testing
What is RD06-03 cell injection?
RD06-03 cell injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b lymphoblastic leukemia/lymphoma.
Also referred to as RD06-03.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 70
You may be able to join if
- 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...
- Ph+ALL people are eligible if they meet one of the following criteria: ① Relapse or refractory after receiving at least 2 tyrosine kinase inhibitors...
- The proportion of bone marrow blasts during the screening period is ≥5% (morphological).Expression of CD19 on bone marrow or peripheral blood tumor...
- Organ function and laboratory tests meet the following criteria: Serum total bilirubin \<2× upper limit of normal (ULN), serum ALT and AST both \<3×...
You likely can't join if
- 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...
- Significant cardiovascular dysfunction within 12 months before screening, including but not limited to: New York Heart Association (NYHA) class III...
See the full eligibility 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...
- Ph+ALL people 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...
- 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...
- 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...
- 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...
- people 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...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.