RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL (NCT05902845) | Clinical Trial Compass
CompletedEarly Phase 1
RD13-02 CAR-T Cell Injection for Patients With r/r CD7+ T-ALL/T-LBL
China4 participantsStarted 2023-04-30
Plain-language summary
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
Who can participate
Age range
3 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 3-70
. Diagnosis of r/r T-ALL/LBL.
. CD7 positive expression
. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
. Left ventricular ejection fraction ≥ 50% .
. Baseline oxygen saturation ≥ 92% on room air.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate, ORR
Timeframe: Evaluate at 4 weeks after CAR-T infusion
2
Overall response rate, ORR
Timeframe: Evaluate at 8 weeks after CAR-T infusion
3
Overall response rate, ORR
Timeframe: Evaluate at 12 weeks after CAR-T infusion
. Sujects with concomitant genetic syndromes associated with bone marrow failure states.
. Sujects with some cardiac conditions will be excluded.
. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
. History of malignancy other than non-melanoma skin cancer or carcinoma.
. Primary immune deficiency.
. Presence of uncontrolled infections.
. Sujects with some anticancer therapy before CAR-T infusion will be excluded.