CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

Sponsor
Caribou Biosciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04637763
Collaborator
(none)
50
Enrollment
6
Locations
2
Arms
51.2
Anticipated Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

Detailed Description

This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The CB10A clinical study consists of 3 + 3 design with three dose levels.The CB10A clinical study consists of 3 + 3 design with three dose levels.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Dose Escalation of CB-010

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Genetic: CB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Drug: Fludarabine
Chemotherapy for lymphodepletion

Experimental: Expansion of CB-010

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Genetic: CB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Drug: Fludarabine
Chemotherapy for lymphodepletion

Outcome Measures

Primary Outcome Measures

  1. Primary outcome measures number of patients with dose-limiting toxicities (Part A). [28 days following CB-010 infusion]

    Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.

  2. Primary outcome evaluates tumor response (Part B) [Up to 12 months]

    The primary endpoint is objective response rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age greater than or equal to 18 at the time of enrollment

  • Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care

  • Eastern Cooperative Oncology Group performance status 0 or 1

  • Adequate hematologic, renal, liver, cardiac and pulmonary organ function

Exclusion Criteria:
  • Prior therapy with an anti-CD19 targeting agent

  • Active or chronic graft versus host disease requiring therapy

  • Prior allogeneic stem cell transplantation

  • Central nervous system (CNS) lymphoma, prior CNS malignancy

  • Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.

  • Primary immunodeficiency

  • Current or expected need for systemic corticosteroid therapy

  • Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted

  • Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence

  • Unwillingness to follow extended safety monitoring

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1HonorHealthScottsdaleArizonaUnited States85258
2University of California San Diego Moores Cancer CenterLa JollaCaliforniaUnited States92073
3Chao Family Comprehensive Cancer Center/University of California IrvineOrangeCaliforniaUnited States92868
4Oncology Hematology CareCincinnatiOhioUnited States45242
5Baylor Charles A. Sammons Cancer CenterDallasTexasUnited States75246
6MD Anderson Cancer CenterHoustonTexasUnited States77030-4009

Sponsors and Collaborators

  • Caribou Biosciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caribou Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT04637763
Other Study ID Numbers:
  • CB10A
First Posted:
Nov 20, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022