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New treatment option for CD7-positive Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma
Official title PA3-17 Injection in Adult Patients With CD7-positive Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
ClinicalTrials.gov ID: NCT07188610
What this study is testing
What is T cell injection targeting CD7 chimeric antigen receptor?
T cell injection targeting CD7 chimeric antigen receptor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cd7-positive relapsed/refractory t lymphoblastic leukemia/lymphoma.
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
- \ \ Translation:\ \ This clinical trial is designed as a single-arm, open-label, multicenter study. After signing the informed consent form, eligible subjects will undergo a single nucleated cell collection for the preparation of CAR-T cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age and Gender: ≥18 years old (inclusive), regardless of gender.
- Survival Expectancy: ≥3 months.
- Performance Status: ECOG score 0-1.
- Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of...
- Recurrent or Refractory Disease: people with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
You likely can't join if
- Known to have active or uncontrolled autoimmune diseases;
- Presence of GvHD;
- History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal...
- Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
- Severe heart disease;
- Unstable systemic diseases as judged by the investigator;
See the full eligibility criteria
- Age and Gender: ≥18 years old (inclusive), regardless of gender.
- Survival Expectancy: ≥3 months.
- Performance Status: ECOG score 0-1.
- Diagnosis: Confirmed acute T-cell lymphoblastic leukemia/lymphoma (T-ALL/LBL) according to the WHO fifth edition of the "Classification of Hematopoietic and Lymphoid Tumors," including early T-cell precursor (ETP).
- Recurrent or Refractory Disease: people with recurrent/refractory T-ALL/LBL (including ETP-ALL/LBL).
- Screening: Abnormal cells CD7 expression positive.
- Lesion Assessment: If the subject has only extramedullary lesions, they must have evaluable lesions.
- Meet the requirements of liver, kidney, heart, and lung functions.
- No Severe Mental Disorders.
- Informed Consent: Ability to understand the trial and signed informed consent form.
- Known to have active or uncontrolled autoimmune diseases;
- Presence of GvHD;
- History of malignant tumors other than T-ALL/LBL within the past 5 years, except for adequately treated cervical intraepithelial neoplasia, basal cell or squamous cell skin cancer, locally treated prostate cancer, and...
- Positive test results for hepatitis B, hepatitis C, syphilis, etc.;
- Severe heart disease;
- Unstable systemic diseases as judged by the investigator;
- Presence of active infection or uncontrollable infection requiring systemic treatment;
- Pregnant or breastfeeding women, and female people planning to conceive within 2 years after cell infusion, or male people whose partners plan to conceive within 2 years after cell infusion;
- people who have received CAR-T therapy or other gene-modified cell therapy before screening;
- Participation in other clinical studies within 1 month before screening (end date of the last application of unapproved innovative drugs);
- Evidence of central nervous system involvement at the time of subject screening;
- Situations judged by the investigator as not suitable for cell preparation;
- Other circumstances deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 7 more location(s). 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.