A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies

Recruiting Phase 1 Phase 2 Interventional Study
T-Cell Acute Lymphocytic Leukemia Acute Lymphoblastic Leukemia, in Relapse Refractory Acute Lymphoblastic Leukemia T-cell Malignancies
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
Beijing GoBroad Hospital · Other
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About This Trial
This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Only patients who meet all the following criteria can be included: 1\. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently avai…
Contacts

Shaocong Miao

86+18831006667

miaosc@gobroadhealthcare.com

CONTACT